Trial Outcomes & Findings for A Phase I Trial of Anti-GD2 T-cells (1RG-CART) (NCT NCT02761915)
NCT ID: NCT02761915
Last Updated: 2021-08-17
Results Overview
Feasibility of 1RG-CART therapy assessed as the number of patients who commence T-cell processing and are subsequently evaluable for 1RG-CART engraftment at Day 14.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Day 14
Results posted on
2021-08-17
Participant Flow
17 trial participants were enrolled at one trial site between 29 February 2016 and 19 November 2019.
Participant milestones
| Measure |
Dose Level 1
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART/m\^2
|
Dose Level 4
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART/m\^2
|
Dose Level 5
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
1
|
3
|
3
|
5
|
|
Overall Study
Underwent Leukapheresis
|
4
|
1
|
1
|
3
|
3
|
5
|
|
Overall Study
Received Investigational Medicinal Product
|
4
|
1
|
1
|
3
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
3
|
3
|
5
|
Reasons for withdrawal
| Measure |
Dose Level 1
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART/m\^2
|
Dose Level 4
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART/m\^2
|
Dose Level 5
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
3
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Disease Progression
|
0
|
0
|
0
|
2
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=4 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
1RG-CART
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Cyclophosphamide
Fludarabine
Leukapheresis
1RG-CART
|
Dose Level 4
n=3 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Cyclophosphamide
Fludarabine
Leukapheresis
1RG-CART
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Cyclophosphamide
Fludarabine
Leukapheresis
1RG-CART
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
n=5 Participants
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=17 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=4 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: All eligible patients enrolled for leukapheresis/venepuncture. Patients who were enrolled for leukapheresis/venepuncture in error (due to ineligibility or administrative error) were excluded.
Feasibility of 1RG-CART therapy assessed as the number of patients who commence T-cell processing and are subsequently evaluable for 1RG-CART engraftment at Day 14.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=3 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
n=5 Participants
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
To Evaluate the Feasibility of 1RG-CART Therapy in Patients With Relapsed or Refractory Neuroblastoma
Underwent Leukapheresis only
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
To Evaluate the Feasibility of 1RG-CART Therapy in Patients With Relapsed or Refractory Neuroblastoma
Underwent Leukapheresis and received 1RG-CART
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])Population: All eligible patients who received at least one dose of 1RG-CART, cyclophosphamide or fludarabine.
Number of serious adverse events, non-serious adverse events and adverse events that are related to fludarabine, cyclophosphamide or 1RG-CART.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=3 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability of 1RG-CART Therapy
SAEs
|
0 Events
|
0 Events
|
0 Events
|
5 Events
|
7 Events
|
—
|
|
Safety and Tolerability of 1RG-CART Therapy
NSAEs
|
31 Events
|
13 Events
|
15 Events
|
75 Events
|
86 Events
|
—
|
|
Safety and Tolerability of 1RG-CART Therapy
Fludarabine Related AEs
|
NA Events
Dose Level 1 patients did not receive fludarabine or cyclophosphamide conditioning regimen.
|
NA Events
Dose Level 2 patients did not receive fludarabine conditioning regimen.
|
7 Events
|
18 Events
|
25 Events
|
—
|
|
Safety and Tolerability of 1RG-CART Therapy
Cyclophosphamide Related AEs
|
NA Events
Dose Level 1 patients did not receive fludarabine or cyclophosphamide conditioning regimen.
|
8 Events
|
7 Events
|
18 Events
|
27 Events
|
—
|
|
Safety and Tolerability of 1RG-CART Therapy
1RG-CART Related AEs
|
4 Events
|
2 Events
|
0 Events
|
25 Events
|
33 Events
|
—
|
PRIMARY outcome
Timeframe: From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])Population: All eligible patients who received at least one dose of 1RG-CART, cyclophosphamide or fludarabine.
Number of dose limiting toxicities (DLTs) at each dose level.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=3 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
To Determine Recommended Phase II Regimen by Assessing the Number of DLTs at Each Dose Level
|
0 DLT events
|
0 DLT events
|
0 DLT events
|
0 DLT events
|
0 DLT events
|
—
|
SECONDARY outcome
Timeframe: From Day 0 until end of trial (median 38.5 days, range 20 to 233 days)Population: All eligible patients who received 1RG-CART and provided at least one post-treatment blood sample taken on or after Day 14 for 1RG-CART analysis.
Number of patients with 1RG-CART levels in peripheral blood above the limit of quantification for the assay (10 cells/µL) by flow cytometry.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=3 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
1RG-CART Counts in the Peripheral Blood
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 28, 2 months and 4 monthsPopulation: All eligible patients who received at least one dose of 1RG-CART and had a baseline assessment of disease and at least one repeat disease assessment measured according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Assessment of best tumour response from baseline according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=2 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
Assessment of Tumour Response From Baseline (RECIST)
Best Response (RECIST) stable disease (SD)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Assessment of Tumour Response From Baseline (RECIST)
Best Response (RECIST) progressive disease (PD)
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 28, 2 months and 4 monthsPopulation: All eligible patients who received at least one dose of 1RG-CART and had a baseline assessment of disease and at least one repeat disease assessment measured according to Immune Related Response Criteria (irRC).
Assessment of best tumour response from baseline according to Immune Related Response Criteria (irRC).
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=2 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
Assessment of Tumour Response From Baseline (irRC)
Best Response (irRC) stable disease (irSD)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Assessment of Tumour Response From Baseline (irRC)
Best Response (irRC) progressive disease (irPD)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Assessment of Tumour Response From Baseline (irRC)
Best Response (irRC) not evaluable (NE)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 28, 2 months and 4 monthsPopulation: All eligible patients who received at least one dose of 1RG-CART and had a baseline assessment of disease and at least one repeat disease assessment measured according to International Neuroblastoma Response Criteria (INRC).
Assessment of best tumour response from baseline according to International Neuroblastoma Response Criteria (INRC).
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=2 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
Assessment of Tumour Response From Baseline (INRC)
Best Response (INRC) Mixed response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Assessment of Tumour Response From Baseline (INRC)
Best Response (INRC) No response
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Assessment of Tumour Response From Baseline (INRC)
Best Response (INRC) Progressive disease
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All eligible patients who received 1RG-CART and completed a baseline assessment of disease and at least one repeat disease assessment.
Progression free survival (progression by RECIST criteria).
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=2 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
To Evaluate Anti-tumour Activity (Progression Free Survival)
|
122 Days
Interval 28.0 to 125.0
|
34 Days
Only one patient. Data indicate death, as patient died without radiological progression being documented.
|
113 Days
Only one patient. Data indicate death, as patient died without radiological progression being documented.
|
39.5 Days
Interval 28.0 to 51.0
|
27 Days
Interval 22.0 to 65.0
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients who received 1RG-CART.
Overall survival.
Outcome measures
| Measure |
Dose Level 1
n=4 Participants
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 Participants
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide
1RG-CART/m\^2
|
Dose Level 3
n=1 Participants
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 4
n=3 Participants
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Dose Level 5
n=3 Participants
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis Cyclophosphamide Fludarabine
1RG-CART/m\^2
|
Patients Who Underwent Leukapheresis But Did Not Proceed to Receive Any IMP
Patients who were enrolled and underwent leukapheresis but who did not receive any IMP.
Assigned Interventions:
Leukapheresis
|
|---|---|---|---|---|---|---|
|
To Evaluate Anti-tumour Activity (Overall Survival)
|
170 Days
Interval 84.0 to 752.0
|
261 Days
Only one patient.
|
113 Days
Only one patient.
|
60 Days
Interval 51.0 to 64.0
|
NA Days
Time to death was not collected for any patients at this dose level. One patient withdrew consent for the trial and two patients were withdrawn due to progressive disease and difficult follow-up.
|
—
|
Adverse Events
Dose Level 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 3 deaths
Dose Level 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Dose Level 5
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 participants at risk
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
1RG-CART
|
Dose Level 3
n=1 participants at risk
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART
|
Dose Level 4
n=3 participants at risk
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART
|
Dose Level 5
n=3 participants at risk
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Pain
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
Other adverse events
| Measure |
Dose Level 1
n=4 participants at risk
Patients in Dose Level 1 will receive 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
1RG-CART
|
Dose Level 2
n=1 participants at risk
Patients in Dose Level 2 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -4 to -1) followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
1RG-CART
|
Dose Level 3
n=1 participants at risk
Patients in Dose Level 3 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^7 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART
|
Dose Level 4
n=3 participants at risk
Patients in Dose Level 4 will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 1x10\^8 1RG-CART/m\^2 IV on Day 0.
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART
|
Dose Level 5
n=3 participants at risk
If the required level of 1RG-CART survival is not reached, a further cohort of patients (Dose Level 5) will receive 300 mg/m\^2/day of cyclophosphamide for four days (Days -7 to -4) and 25 mg/m\^2/day of fludarabine for five days (Days -8 to -4), followed by 5-10x10\^8 1RG-CART/m\^2 IV which could be be split over two days (Day 0 and Day 1).
Assigned Interventions:
Leukapheresis
Cyclophosphamide
Fludarabine
1RG-CART
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 5 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Eye disorders
Diplopia
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Localised oedema
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Pain
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Pyrexia
|
50.0%
2/4 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Swelling
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
General disorders
Swelling face
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Hepatobiliary disorders
Jaundice
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Lower respiratory tract infection
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Infections and infestations
Vascular device infection
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Alanine aminotransferase increased
|
75.0%
3/4 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Blood lactate dehydrogenase increased
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
C-reactive protein increased
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 5 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 6 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
3/3 • Number of events 6 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Investigations
White blood cells urine positive
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Fluid overload
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
2/4 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 5 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
66.7%
2/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
100.0%
1/1 • Number of events 2 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Surgical and medical procedures
Oxygen therapy
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
0.00%
0/3 • From the time of informed consent to leukapheresis until withdrawal from the trial or start of other anti-cancer therapy (a median time period of 132 days [range 68 to 301 days])
Adverse events are reported for those patients who received IMP (fludarabine, cyclophosphamide or 1RG-CART) on the trial. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.02 or trial-specific (protocol defined) grading scheme for cytokine release syndrome (CRS) was used to grade AE severity.
|
Additional Information
Regulatory Affairs Manager
Cancer Research UK Centre for Drug Development
Phone: +44 203 4696878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place