Trial Outcomes & Findings for Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab (NCT NCT03709706)
NCT ID: NCT03709706
Last Updated: 2024-02-23
Results Overview
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Up to approximately 10 months
Results posted on
2024-02-23
Participant Flow
This was an open-label study that evaluated the safety and tolerability of autologous T-cells expressing enhanced T-cell receptors (TCRs) that were specific for New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) (GSK3377794, Lete-cel) in participants with Advanced or Recurrent Non-Small Cell Lung Cancer who had Human Leukocyte Antigen (HLA)-A02:01, HLA-A02:05, and/or HLA-A\*02:06.
A total of 34 participants were enrolled in this study, out of which 13 received Lete-cel infusion. The study was terminated due to reasons pertaining to feasibility As a result of the early termination, no participants were assigned to Arm B, and thus no analysis of Arm B was performed.
Participant milestones
| Measure |
Arm A: Lete-cel Monotherapy
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
14
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
20
|
14
|
|
Overall Study
Modified - Intent to Treat Population
|
7
|
6
|
|
Overall Study
No Treatment
|
13
|
8
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
17
|
11
|
Reasons for withdrawal
| Measure |
Arm A: Lete-cel Monotherapy
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Physician Decision
|
14
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Death Prior to Lete-cel Infusion
|
1
|
1
|
Baseline Characteristics
Pilot Immunotherapy Study With Letetresgene Autoleucel (Lete-cel, GSK3377794)T-cells in New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1)/ LAGE-1a-positive Advanced Non-small Cell Lung Cancer (NSCLC) Either Alone or in Combination With Pembrolizumab
Baseline characteristics by cohort
| Measure |
Arm A: Lete-cel Monotherapy
n=20 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=14 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 YEARS
STANDARD_DEVIATION 8.90 • n=5 Participants
|
59.4 YEARS
STANDARD_DEVIATION 10.25 • n=7 Participants
|
61.0 YEARS
STANDARD_DEVIATION 9.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified Intent-to-Treat (mITT) population included all participants who received Lete-cel infusion.
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
7 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified Intent to Treat (mITT) population.
AESI included cytokine release syndrome (CRS), pneumonitis/pneumonia, graft vs host disease (GvHD), guillain barre syndrome (GBS) or acute inflammatory demyelinating polyneuropathy (AIDP), pancytopenia/aplastic anemia (including analysis of all hematopoietic cytopenias), immune effector cell-associated neurotoxicity syndrome (ICANS) and treatment-related inflammatory response at tumor site. AEs which start or worsen on or after T-cell infusion are defined as treatment-emergent.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population
An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. AEs which start or worsen on or after T-cell infusion are defined as TE. Severity was reported during study and was assigned a grade according to the National Institutes of Health National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). SAEs are subset of AEs. AEs and SAEs severity graded on a 5-point scale as: 1 = mild, 2 = moderate discomfort, 3 = severe, 4 = life-threatening and 5 = death due to AE.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
AEs, Grade 2
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
AEs, Grade 3
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
AEs, Grade 4
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
AEs, Grade 5
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
SAEs, Grade 3
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
SAEs, Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events Based on Maximum Severity Grades
SAEs, Grade 5
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population
An AE is any untoward medical occurrence in a clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to dose delays were summarized.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Number of Participants With AEs Leading to Dose Delays
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population
Overall response rate (ORR) defined as the percentage of participants with a complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria in Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population
Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Progression-free Survival (PFS) Per RECIST Version 1.1 by Investigator Assessment
|
5.32 Months
Interval 1.45 to 5.52
|
1.48 Months
Interval 0.62 to 2.83
|
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population
DCR was defined as the percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months as per RECIST v1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population. Only participants with CR or PR were included in the analysis. No participant achieved CR or PR, hence the number of participants analyzed is 0.
Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Modified intent-to-treat (mITT) population. Only participants with CR or PR were included in the analysis. No participant achieved CR or PR, hence the number of participants analyzed is 0.
Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: Pharmacokinetic (PK) population included all participants in the mITT population from whom at least one PK sample was obtained, analyzed, and was measurable.
Cmax was defined as peak cell expansion during the study. Blood samples were collected for analysis of Cmax of lete-cel.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Maximum Transgene Expansion (Cmax) of Lete-cel
|
155712.1398 Copies per microgram genomic DNA
Geometric Coefficient of Variation 55.21519
|
127343.0679 Copies per microgram genomic DNA
Geometric Coefficient of Variation 34.95574
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: Pharmacokinetic (PK) population
Tmax was defined as time to reach peak cell expansion during the study. Blood samples were collected for analysis of Tmax of lete-cel.
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Time to Cmax (Tmax) of Lete-cel
|
3 Days
Interval 1.0 to 15.0
|
7.9 Days
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: Pharmacokinetic (PK) population
Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).
Outcome measures
| Measure |
Arm A: Lete-cel Monotherapy
n=7 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 Participants
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
|---|---|---|
|
Area Under the Plasma Concentration-time Curve to Day 28 (AUC0-28d) of Lete-cel
|
1646416.5835 Days*copies per microgram genomic DNA
Geometric Coefficient of Variation 109.45757
|
1565617.646 Days*copies per microgram genomic DNA
Geometric Coefficient of Variation 46.16918
|
Adverse Events
Arm A: Lete-cel Monotherapy
Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths
Arm C: Lete-cel + Pembrolizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
No Treatment
Serious events: 2 serious events
Other events: 3 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Arm A: Lete-cel Monotherapy
n=7 participants at risk
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 participants at risk
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
No Treatment
n=21 participants at risk
Participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy or T-cell infusion.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Cardiac disorders
Pericardial effusion
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Fatigue
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Immune system disorders
Cytokine release syndrome
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Bacteraemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Empyema
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
Other adverse events
| Measure |
Arm A: Lete-cel Monotherapy
n=7 participants at risk
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T- cell receptors (TCR) specific for NY-ESO-1/LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel. Participants who had disease progression within 25 weeks of Lete-cel infusion were offered therapy with Pembrolizumab following benefit-risk evaluation. Pembrolizumab 200 mg was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until subsequent disease progression or intolerable toxicity. Pembrolizumab therapy was not allowed if disease progression occurred post 25 weeks of Lete-cel infusion.
|
Arm C: Lete-cel + Pembrolizumab
n=6 participants at risk
Eligible participants underwent leukapheresis to manufacture autologous T cells bearing T-cell receptors (TCR) specific for NY-ESO-1 /LAGE-1a. Lymphodepleting chemotherapy was administered, consisting of cyclophosphamide at a dose of 900 mg/m\^2/day on day -7 through day -5 and fludarabine at a dose of 30 mg/m\^2/day on day -8 through day -5. On day 1, participants received a single infusion of Lete-cel followed by pembrolizumab 200 mg starting on Day 22 (Week 4 Day 1). Pembrolizumab was administered every three weeks (Q3W) for up to 35 cycles (up to Week 106) or until disease progression, whichever occurred first.
|
No Treatment
n=21 participants at risk
Participants who underwent leukapheresis but did not go on to receive lymphodepletion chemotherapy or T-cell infusion.
|
|---|---|---|---|
|
Investigations
Blood fibrinogen decreased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Blood and lymphatic system disorders
Anaemia
|
71.4%
5/7 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
83.3%
5/6 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Blood and lymphatic system disorders
Leukopenia
|
28.6%
2/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
14.3%
1/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Blood and lymphatic system disorders
Neutropenia
|
42.9%
3/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Cardiac disorders
Atrial flutter
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Eye disorders
Dry eye
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
50.0%
3/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Dry mouth
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Haematemesis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Lip dry
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Oral disorder
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
50.0%
3/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Asthenia
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Chills
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Face oedema
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Facial pain
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Malaise
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Mucosal inflammation
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Oedema
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
General disorders
Pyrexia
|
71.4%
5/7 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Immune system disorders
Cytokine release syndrome
|
57.1%
4/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
66.7%
4/6 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Immune system disorders
Hypersensitivity
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Conjunctivitis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Infections and infestations
Rash pustular
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Injury, poisoning and procedural complications
Radiation necrosis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Blood creatinine increased
|
28.6%
2/7 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Blood fibrinogen increased
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Blood methaemoglobin present
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
C-reactive protein increased
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Haemoglobin decreased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
International normalised ratio increased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
7/7 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
66.7%
4/6 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Neutrophil count decreased
|
42.9%
3/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
66.7%
4/6 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Platelet count decreased
|
57.1%
4/7 • Number of events 5 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Serum ferritin increased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Urine output decreased
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
Weight decreased
|
28.6%
2/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Investigations
White blood cell count decreased
|
85.7%
6/7 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
71.4%
5/7 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
50.0%
3/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
1/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.6%
2/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
28.6%
2/7 • Number of events 6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
57.1%
4/7 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Metabolism and nutrition disorders
Malnutrition
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
50.0%
3/6 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Cognitive disorder
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Dysarthria
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Immune effector cell-associated neurotoxicity syndrome
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Psychiatric disorders
Depression
|
42.9%
3/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Psychiatric disorders
Hallucination
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
4.8%
1/21 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Chronic kidney disease
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
2/7 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
42.9%
3/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
33.3%
2/6 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.1%
4/7 • Number of events 4 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
50.0%
3/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
50.0%
3/6 • Number of events 3 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Vascular disorders
Haematoma
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Vascular disorders
Hypotension
|
28.6%
2/7 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
16.7%
1/6 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
|
Vascular disorders
Orthostatic hypotension
|
14.3%
1/7 • Number of events 1 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/6 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
0.00%
0/21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 10 months
All cause mortality , SAEs and non-serious adverse events were reported for the Intent to Treat (ITT) population that includes all participants who started the leukapheresis procedure. Participants in the "No Treatment" arm started the leukapheresis procedure but did not receive lymphodepletion chemotherapy or Lete-cel infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER