Trial Outcomes & Findings for Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL (NCT NCT04030195)
NCT ID: NCT04030195
Last Updated: 2023-01-31
Results Overview
The maximum tolerated dose (MTD) is the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Day 1 to Day 28
Results posted on
2023-01-31
Participant Flow
20 participants were screened for this study, of whom 2 screen failed.
Participant milestones
| Measure |
Dose Level 1 of PBCAR20A CAR T Cells
1 x 10\^6 CAR T cells per kg body weight.
In this study, PBCAR20A, allogeneic anti-CD20 CAR T Cells, is used to treat patients with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Route of Administration: Intravenous infusion.
Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
PBCAR20A: Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Fludarabine: Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
Cyclophosphamide: Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).
|
Dose Level 2 of PBCAR20A CAR T Cells
240 x 10\^6 CAR T cells (flat dose)
PBCAR20A: Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Fludarabine: Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
Cyclophosphamide: Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).
|
Dose Level 3 of PBCAR20A CAR T Cells
480 x 10\^6 CAR T cells (flat dose)
PBCAR20A: Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Fludarabine: Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
Cyclophosphamide: Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
7
|
|
Overall Study
Participants in Demographic Population
|
8
|
3
|
6
|
|
Overall Study
Participants in Safety Population
|
8
|
3
|
6
|
|
Overall Study
Participants Re-treated
|
0
|
0
|
1
|
|
Overall Study
Participants in Efficacy Population
|
8
|
3
|
7
|
|
Overall Study
COMPLETED
|
6
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1 of PBCAR20A CAR T Cells
1 x 10\^6 CAR T cells per kg body weight.
In this study, PBCAR20A, allogeneic anti-CD20 CAR T Cells, is used to treat patients with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Route of Administration: Intravenous infusion.
Lymphodepletion Conditioning: Lymphodepletion will be conducted several days prior to PBCAR20A infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.
PBCAR20A: Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Fludarabine: Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
Cyclophosphamide: Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).
|
Dose Level 2 of PBCAR20A CAR T Cells
240 x 10\^6 CAR T cells (flat dose)
PBCAR20A: Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Fludarabine: Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
Cyclophosphamide: Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).
|
Dose Level 3 of PBCAR20A CAR T Cells
480 x 10\^6 CAR T cells (flat dose)
PBCAR20A: Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic "3+3" dose escalation will be applied.
Fludarabine: Fludarabine is used for lymphodepletion (30 mg/m\^2/day, Days -5 to -3).
Cyclophosphamide: Cyclophosphamide is used for lymphodepletion (500 mg/m\^2/day, Days -5 to -3).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Dose-escalation Study of Safety of PBCAR20A in Subjects With r/r NHL or r/r CLL/SLL
Baseline characteristics by cohort
| Measure |
Dose Level 1 of PBCAR20A CAR T Cells
n=8 Participants
1 x 10\^6 CAR T cells per kg body weight
|
Dose Level 2 of PBCAR20A CAR T Cells
n=3 Participants
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
n=6 Participants
480 x 10\^6 CAR T cells (flat dose)
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.25 years
STANDARD_DEVIATION 17.07 • n=93 Participants
|
47.00 years
STANDARD_DEVIATION 19.08 • n=4 Participants
|
58.17 years
STANDARD_DEVIATION 13.70 • n=27 Participants
|
56.24 years
STANDARD_DEVIATION 15.85 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
17 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: All participants. The participant who was dosed twice at Dose Level 3 (DL3) was counted as 2 individual participants.
The maximum tolerated dose (MTD) is the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
Outcome measures
| Measure |
PBCAR20A CAR T Cells
n=18 Participants
All participants who received PBCAR20A CAR T Cells at any dose level
|
Dose Level 2 of PBCAR20A CAR T Cells
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
480 x 10\^6 CAR T cells (flat dose)
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA 10^6 CAR T cells
MTD was not reached in this study because MTD requires at least 2 dose limiting toxicities (DLTs) in any given dose level and only 1 DLT was noted.
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All participants. The participant who was dosed twice at DL3 was counted as 2 individual participants.
Dose-limiting toxicities (DLT) are certain Grade 3 and Grade 4 toxic reactions as defined by the protocol and CTCAE v5.0.
Outcome measures
| Measure |
PBCAR20A CAR T Cells
n=8 Participants
All participants who received PBCAR20A CAR T Cells at any dose level
|
Dose Level 2 of PBCAR20A CAR T Cells
n=3 Participants
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
n=7 Participants
480 x 10\^6 CAR T cells (flat dose)
|
|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants. The participant who was dosed twice at DL3 was counted as 2 individual participants.
Objective response rate (ORR) is a measure of clinical activity as response in NHL by the revised Lugano Classification (Cheson et al, 2016) or a response in CLL/SLL by the International Workshop on Chronic Lymphocytic Leukemia 2018 guidelines.
Outcome measures
| Measure |
PBCAR20A CAR T Cells
n=8 Participants
All participants who received PBCAR20A CAR T Cells at any dose level
|
Dose Level 2 of PBCAR20A CAR T Cells
n=3 Participants
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
n=7 Participants
480 x 10\^6 CAR T cells (flat dose)
|
|---|---|---|---|
|
Objective Response Rate
Responders
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Objective Response Rate
Complete Response
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate
Partial Response
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Objective Response Rate
Non-responders
|
6 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants. The participant who was dosed twice at DL3 was counted as 2 individual participants.
Progression-free survival is defined as the duration (days) from Day 0 to disease progression or death.
Outcome measures
| Measure |
PBCAR20A CAR T Cells
n=8 Participants
All participants who received PBCAR20A CAR T Cells at any dose level
|
Dose Level 2 of PBCAR20A CAR T Cells
n=3 Participants
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
n=7 Participants
480 x 10\^6 CAR T cells (flat dose)
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
29.5 Days
Interval 15.0 to 365.0
|
29.0 Days
Interval 29.0 to 94.0
|
29.0 Days
Interval 12.0 to 66.0
|
Adverse Events
Dose Level 1 of PBCAR20A CAR T Cells
Serious events: 3 serious events
Other events: 8 other events
Deaths: 1 deaths
Dose Level 2 of PBCAR20A CAR T Cells
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 3 of PBCAR20A CAR T Cells
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1 of PBCAR20A CAR T Cells
n=8 participants at risk
1 x 10\^6 CAR T cells per kg body weight
|
Dose Level 2 of PBCAR20A CAR T Cells
n=3 participants at risk
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
n=6 participants at risk
480 x 10\^6 CAR T cells (flat dose)
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Transaminases increased
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CAR T cell-related encephalopathy syndrome
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
Other adverse events
| Measure |
Dose Level 1 of PBCAR20A CAR T Cells
n=8 participants at risk
1 x 10\^6 CAR T cells per kg body weight
|
Dose Level 2 of PBCAR20A CAR T Cells
n=3 participants at risk
240 x 10\^6 CAR T cells (flat dose)
|
Dose Level 3 of PBCAR20A CAR T Cells
n=6 participants at risk
480 x 10\^6 CAR T cells (flat dose)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
6/8 • Number of events 13 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
50.0%
3/6 • Number of events 8 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
2/6 • Number of events 3 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Anal incontinence
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 2 • 1 year
|
66.7%
2/3 • Number of events 5 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • Number of events 3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
2/6 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
2/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
37.5%
3/8 • Number of events 3 • 1 year
|
66.7%
2/3 • Number of events 4 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
33.3%
2/6 • Number of events 2 • 1 year
|
|
General disorders
Asthenia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
General disorders
Chills
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 6 • 1 year
|
66.7%
2/3 • Number of events 4 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
General disorders
Gait disturbance
|
12.5%
1/8 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Generalised oedema
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Oedema peripheral
|
37.5%
3/8 • Number of events 3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
66.7%
4/6 • Number of events 7 • 1 year
|
|
General disorders
Peripheral swelling
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
General disorders
Pyrexia
|
50.0%
4/8 • Number of events 5 • 1 year
|
66.7%
2/3 • Number of events 4 • 1 year
|
50.0%
3/6 • Number of events 6 • 1 year
|
|
Immune system disorders
Cytokine release syndrome
|
12.5%
1/8 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
50.0%
3/6 • Number of events 3 • 1 year
|
|
Infections and infestations
Escherichia bacteraemia
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Human herpesvirus 6 infection
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Oral candidiasis
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
2/8 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
2/8 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
2/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Investigations
Neutrophil count decreased
|
75.0%
6/8 • Number of events 11 • 1 year
|
66.7%
2/3 • Number of events 3 • 1 year
|
66.7%
4/6 • Number of events 10 • 1 year
|
|
Investigations
Platelet count decreased
|
37.5%
3/8 • Number of events 4 • 1 year
|
0.00%
0/3 • 1 year
|
50.0%
3/6 • Number of events 7 • 1 year
|
|
Investigations
Urine output decreased
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
Weight decreased
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
Weight increased
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Investigations
White blood cell count decreased
|
37.5%
3/8 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
50.0%
3/6 • Number of events 5 • 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
3/8 • Number of events 6 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
2/6 • Number of events 5 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
37.5%
3/8 • Number of events 5 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
2/6 • Number of events 7 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
2/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
1/8 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
16.7%
1/6 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
25.0%
2/8 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Number of events 1 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
CAR T-cell-related encephalopathy syndrome
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 3 • 1 year
|
66.7%
2/3 • Number of events 4 • 1 year
|
33.3%
2/6 • Number of events 3 • 1 year
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Somnolence
|
25.0%
2/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Confusional state
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Psychiatric disorders
Restlessness
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Reproductive system and breast disorders
Scrotal oedema
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Reproductive system and breast disorders
Scrotal pain
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Reproductive system and breast disorders
Testicular oedema
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
12.5%
1/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/6 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/6 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • 1 year
|
0.00%
0/3 • 1 year
|
16.7%
1/6 • Number of events 1 • 1 year
|
Additional Information
Michael Karg, Senior Director, Clinical Operations
Precision BioSciences
Phone: 919-324-5512
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place