Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Conditions
Brief summary
The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).
Detailed description
Bridging therapy could be administered at the discretion of the investigator and is recommended for participants with high disease burden at baseline (M3 marrow \[\> 25% leukemic blasts\] or ≥ 1,000 blasts/mm\^3 in the peripheral circulation) to control participant's disease prior to conditioning chemotherapy. Bridging therapy includes: Attenuated VAD: Vincristine non-liposomal (1-2 mg IV weekly) or liposomal (2.25 mg/m\^2 IV weekly), and dexamethasone 20-40 mg IV or oral administration (PO) daily x 3-4 days per week. Optional doxorubicin 50 mg/m\^2 IV x 1 (first week only). Mercaptopurine (6-MP): 50-75 mg/m\^2/day by mouth (administer at bedtime on an empty stomach to improve absorption). Hydroxyurea: Doses titrated between 15-50 mg/kg/day (rounded to the nearest 500 mg capsule and given as a single daily oral dose on a continuous basis). DOMP: Dexamethasone 6 mg/m\^2/day PO (or IV) divided twice daily (BID) Days 1-5, vincristine 1.5 mg/m\^2 (maximum dose 2 mg) IV on Day 1, methotrexate 20 mg/m\^2 PO weekly, 6-MP 50- 75mg/m\^2/day PO daily. Attenuated FLAG/FLAG-IDA: fludarabine 30 mg/m\^2 IV days 1-2, cytarabine 2 g/m\^2 IV days 1-2, G-CSF 5 μg/kg subcutaneously (SC) or IV starts on Day 3 and can continue until day before the start of conditioning chemotherapy. With or without idarubicin 6 mg/m\^2 IV Days 1-2. Mini-hyper CVAD (courses A and/or B): * Course A: Cyclophosphamide 150 mg/m\^2 every 12 hours x 3 days, dexamethasone 20 mg/d IV or PO daily Days 1-4 and 11-14, vincristine 2 mg IV x 1 * Course B: Methotrexate 250 mg/m\^2 IV over 24 hours on Day 1,cytarabine 0.5 g/m\^2 IV every 12 hours x 4 doses on Days 2 and 3. After completion of the Month 24 visit, subjects who received an infusion of KTE-X19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968
Interventions
BIOLOGICALbrexucabtagene autoleucel
A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.
DRUGCyclophosphamide
Administered intravenously.
DRUGFludarabine
Administered intravenously.
Sponsors
Kite, A Gilead Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Relapsed or refractory B-precursor ALL defined as one of the following: * Primary refractory disease * First relapse if first remission ≤ 12 months * Relapsed or refractory disease after 2 or more lines of systemic therapy * Relapsed or refractory disease after allogeneic transplant provided individuals is at least 100 days from stem cell transplant at the time of enrollment 2. Morphological disease in the bone marrow (≥ 5% blasts) 3. Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs 4. Eastern cooperative oncology group (ECOG) performance status of 0 or 1 5. Adequate renal, hepatic, pulmonary and cardiac function defined as: * Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome. * Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion, and no clinically significant arrhythmias * Baseline oxygen saturation \> 92% on room air 6. In individuals previously treated with blinatumomab, cluster of differentiation 19 (CD19) tumor expression in bone marrow or peripheral blood. Key
Exclusion criteria
1. Diagnosis of Burkitt's leukemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis 2. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years 3. Isolated extramedullary disease 4. Central nervous system (CNS) abnormalities * Presence of CNS-3 disease or CNS-2 disease with neurological changes * History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement 5. History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome 6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment 7. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. 8. Primary immunodeficiency 9. Known infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive) or hepatitis C virus. 10. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. 11. Prior medication: * Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment * Prior CD19 directed therapy other than blinatumomab * Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis * Donor lymphocyte infusion (DLI) within 28 days prior to enrollment * Any drug used for graft-versus-host disease (GVHD) within 4 weeks prior to enrollment * At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy prior to enrollment * Corticosteroid therapy for 7 days prior to enrollment 12. Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted 13. Acute GVHD grade II-IV by Glucksberg criteria or severity B-D by International Bone Marrow Transplant Registry (IBMTR) index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment 14. Live vaccine ≤ 4 weeks prior to enrollment 15. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential 16. Individuals of both genders of child-bearing potential who are not willing to practice birth control from the time of consent through 6 months after the completion of brexucabtagene autoleucel (KTE-X19) 17. In the investigators judgment, the individuals is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation 18. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation | DLT is drug-related events with onset within first 28 days following infusion: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease * All drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reactions within 2 hours of drug infusion that are reversible ≤ GR 2 within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, GR 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, GR 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, hypogammaglobulinemia GR 3/ 4 and GR 3 nausea and/or anorexia). |
| Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | OCR rate:percentage of participants achieving CR+CRi.CR: ≤5% blasts by morphology in bone marrow(BM);absolute neutrophil count(ANC)≥1000/microliters (μL) and platelets(Plt) ≥100000/μL in peripheral blood(PB);central nervous system extramedullary disease(CNS EMD) of CNS-1(no detectable leukemia in cerebrospinal fluid\[CSF\]);Non-CNS baselineEMD:if present(images shows CR),if no(images not needed),if performed shows negative positron emission tomography(PET) baseline,baseline lesions shows CR as disappearance of measurable and nonmeasurable nodal lesions(Nodal masses \>1.5 cm in greatest transverse diameter\[GTD\] at baseline have regressed to ≤l.5 cm GTD,nodes that were 1.1 to 1.5 cm\[long axis\] and \>1.0 cm\[short axis\] have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions.CRi:all CR criteria except in PB ANC≥1000/μL and Plt\<100000/μL or ANC\<1000/μL and Plt ≥100000/μL.95% confidence interval (CI) was calculated by Clopper-Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. 95% CI was calculated by Clopper-Pearson method. |
| Phase 2: Duration of Remission (DOR) Per Independent Review | From first CR or CRi (Phase 2) up to 3.7 years | DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with \< 5 white blood cells \[WBCs\] per mm\^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm\^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses. |
| Phase 2: OCR Rate (CR + CRi) Per Investigator Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000/µL and Plt \<100000/µL or ANC \<1000/µL and Plt ≥100000/µL. 95% CI was calculated by Clopper-Pearson method. |
| Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | — |
| Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. |
| Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method. |
| Phase 2: Overall Survival (OS) | First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years | OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses. |
| Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method. |
| Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | Up to 5 years | An AE was any untoward medical occurrence in a participant after brexucabtagene autoleucel infusion, which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs included all AEs with onset on or after initiation of the brexucabtagene autoleucel infusion. |
| Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Up to 5 years | Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. |
| Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Up to 5 years | Grading categories are determined by CTCAE version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. |
| Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies | First infusion date of brexucabtagene autoleucel (Phase 2) up to 2.7 years | — |
| Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 | The EQ-5D-5 levels(EQ-5D-5L)is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal.It is a self-reported questionnaire used to assess the overall health status of participant scoring 5 dimensions of health: mobility,self-care,usual activities,pain/discomfort and anxiety/depression.Each dimension has 5 levels:no problems,slight problems,moderate problems,severe problems,and extreme problems.EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by a formula that attaches values (called QOL utilities)to each of the levels in each dimension.EQ-5D Summary Index values range from -0.11(worst health) to 1.00(perfect health).This decision results in a 1-digit number that shows the level for that dimension. The digits for 5 dimensions can be combined to 5-digit number that show the participant's health.Higher scores of EQ-5D-5L indicate better health. |
| Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24 | EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state. |
| Phase 2: Relapse-free Survival (RFS) | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | RFS: time from brexucabtagene autoleucel infusion to date of disease relapse or death from any cause. Participants not meeting criteria for relapse by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who had not achieved a CR or CRi at analysis data cutoff were evaluated as an RFS event at Day 0. CR and CRi are defined in Outcome Measures 4 and 5. Relapse is defined in Outcome Measure 6. KM estimates was used for analyses. |
| Phase 2: Complete Remission (CR) Rate Per Independent Review | First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years | CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. Percentage of participants with CR was reported. 95% CI was calculated by Clopper-Pearson method. |
Countries
Canada, France, Germany, Netherlands, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in France, Germany, the Netherlands, and the United States.
Pre-assignment details
173 participants were screened. Bridging therapy was recommended for all participants particularly those participants with high disease burden at baseline (M3 marrow \[\> 25% leukemic blasts\] or ≥ 1,000 blasts/mm\^3 in the peripheral circulation) to control participant's disease post apheresis/enrollment and prior to conditioning chemotherapy.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered. | 6 |
| Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered. | 23 |
| Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 0.5 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered. | 16 |
| Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg Participants with r/r B-ALL received conditioning chemotherapy (fludarabine 25 mg/m\^2 IV over 30 minutes on Day -4, Day -3, and Day -2 and cyclophosphamide 900 mg/m\^2 IV over 60 minutes on Day -2) followed by a single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered IV at a target dose of 1 x 10\^6 anti-CD19 CAR T cells/kg of body weight on Day 0. For participants weighing \> 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells/kg of body weight was administered. | 55 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 6 | 14 | 11 | 29 |
| Overall Study | Enrolled but did not Initiate KTE-X19 | 0 | 5 | 4 | 16 |
| Overall Study | Full consent withdrawn | 0 | 1 | 0 | 8 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 | 2 |
| Overall Study | Reason not specified | 0 | 2 | 1 | 1 |
| Overall Study | Rolled over or consented to a long term follow-up (LFTU) study | 0 | 4 | 2 | 15 |
Baseline characteristics
| Characteristic | Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 1: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 1: 0.5 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: 1 x 10^6 Anti-CD19 CAR T Cells/kg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 13.8 | 46 years STANDARD_DEVIATION 17.6 | 46 years STANDARD_DEVIATION 16.7 | 42 years STANDARD_DEVIATION 16.1 | 43 years STANDARD_DEVIATION 16.3 |
| Age, Customized <=18 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized >=65 years | 0 Participants | 4 Participants | 3 Participants | 8 Participants | 15 Participants |
| Age, Customized Between 18 and 65 years | 6 Participants | 18 Participants | 13 Participants | 47 Participants | 84 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 3 Participants | 11 Participants | 3 Participants | 11 Participants | 28 Participants |
| Race/Ethnicity, Customized Ethnicity Not collected | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 3 Participants | 12 Participants | 13 Participants | 42 Participants | 70 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Not collected | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Other or More Than One Race | 1 Participants | 1 Participants | 0 Participants | 9 Participants | 11 Participants |
| Race/Ethnicity, Customized Race White | 4 Participants | 19 Participants | 16 Participants | 37 Participants | 76 Participants |
| Region of Enrollment France | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 10 Participants |
| Region of Enrollment Germany | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Region of Enrollment Netherlands | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 6 Participants | 23 Participants | 16 Participants | 41 Participants | 86 Participants |
| Sex: Female, Male Female | 1 Participants | 14 Participants | 8 Participants | 22 Participants | 45 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 8 Participants | 33 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 6 | 17 / 28 | 15 / 20 | 39 / 71 |
| other Total, other adverse events | 6 / 6 | 23 / 23 | 16 / 16 | 55 / 55 |
| serious Total, serious adverse events | 6 / 6 | 21 / 23 | 12 / 16 | 41 / 55 |
Outcome results
Primary
Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
DLT is drug-related events with onset within first 28 days following infusion: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease * All drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reactions within 2 hours of drug infusion that are reversible ≤ GR 2 within 24 hours, renal toxicity which requires dialysis for ≤ 7 days, intubation for airway protection if ≤ 7 days, tumor lysis syndrome, GR 3 liver function test elevation, provided there is resolution to ≤ GR 2 within 14 days, GR 4 transient serum hepatic enzyme abnormalities provided there is resolution to ≤ GR 3 within \< 72 hours, hypogammaglobulinemia GR 3/ 4 and GR 3 nausea and/or anorexia).
Time frame: First infusion date of brexucabtagene autoleucel up to 28 days. Participants were evaluated in specified period but GR4 hematologic toxicity (specified in description) having onset in this period were further observed for 30 days for confirmation
Population: DLT-Evaluable Analysis Set included first 3 participants in Phase 1 treated with target brexucabtagene autoleucel dose and followed for at least 28 days. Only participants from Phase 1: 2 X 10\^6 Anti-CD19 CAR T Cells/kg were pre-specified to be assessed for this Outcome Measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 1: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) | 0 percentage of participants |
Primary
Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review
OCR rate:percentage of participants achieving CR+CRi.CR: ≤5% blasts by morphology in bone marrow(BM);absolute neutrophil count(ANC)≥1000/microliters (μL) and platelets(Plt) ≥100000/μL in peripheral blood(PB);central nervous system extramedullary disease(CNS EMD) of CNS-1(no detectable leukemia in cerebrospinal fluid\[CSF\]);Non-CNS baselineEMD:if present(images shows CR),if no(images not needed),if performed shows negative positron emission tomography(PET) baseline,baseline lesions shows CR as disappearance of measurable and nonmeasurable nodal lesions(Nodal masses \>1.5 cm in greatest transverse diameter\[GTD\] at baseline have regressed to ≤l.5 cm GTD,nodes that were 1.1 to 1.5 cm\[long axis\] and \>1.0 cm\[short axis\] have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions.CRi:all CR criteria except in PB ANC≥1000/μL and Plt\<100000/μL or ANC\<1000/μL and Plt ≥100000/μL.95% confidence interval (CI) was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: The modified Intent-to-Treat (mITT) Analysis Set included all enrolled participants treated with brexucabtagene autoleucel in Phase 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Overall Complete Remission (OCR) Rate (Complete Remission [CR]+ Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed Per Independent Review | 70.9 percentage of participants |
Secondary
Phase 2: Complete Remission (CR) Rate Per Independent Review
CR: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. Percentage of participants with CR was reported. 95% CI was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Complete Remission (CR) Rate Per Independent Review | 56.4 percentage of participants |
Secondary
Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review
CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. Percentage of participants with CRi was reported. 95% CI was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Complete Remission With Incomplete Hematologic Recovery (CRi) Rate Per Independent Review | 14.5 percentage of participants |
Secondary
Phase 2: Duration of Remission (DOR) Per Independent Review
DOR was defined as the time from first CR or CRi to relapse or any death in the absence of documented relapse. CR and CRi are defined in Outcome Measures 4 and 5. Relapse: ≤ 5% blasts by morphology in BM; or circulating leukemia present in PB; or CNS EMD of CNS-2 (detectable CSF blast cells in a sample of CSF with \< 5 white blood cells \[WBCs\] per mm\^3 with neurological changes) or CNS-3 (detectable CSF blast cells in a sample of CSF with ≥ 5 WBCs per mm\^3 with or without neurological changes); or progressive disease (PD): at least one of the following (≥ 50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis; ≥ 50% increase in size of splenic, hepatic or any other non-nodal lesion). Kaplan-Meier (KM) estimates was used for analyses.
Time frame: From first CR or CRi (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set with overall complete remission (CR or CRi ) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Duration of Remission (DOR) Per Independent Review | 14.6 months |
Secondary
Phase 2: EQ-5D Visual Analogue Scale (VAS) Score
EQ-5D is a self-reported questionnaire used for assessing the overall health status of a participant. The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The EQ-5D-VAS records the participant's self-rated health on a 20-cm vertical visual analogue scale and is asked to make a global assessment of their current state of health with 0 indicating the worst health they can imagine and 100 indicating the best health they can imagine. Higher scores indicated a better health state.
Time frame: Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24
Population: Participants in Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Baseline | 68.2 score on a scale | Standard Deviation 21.8 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Day 28 | 74.7 score on a scale | Standard Deviation 17.9 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 3 | 79.7 score on a scale | Standard Deviation 12.2 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 6 | 81.0 score on a scale | Standard Deviation 17.6 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 9 | 81.7 score on a scale | Standard Deviation 23.1 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 12 | 86.9 score on a scale | Standard Deviation 10 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 15 | 87.8 score on a scale | Standard Deviation 11.6 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 18 | 93.3 score on a scale | Standard Deviation 5.9 |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: EQ-5D Visual Analogue Scale (VAS) Score | Month 24 | 97.5 score on a scale | Standard Deviation 2.9 |
Secondary
Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate
MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. Percentage of participants with MRD negative remission was reported. 95% CI was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Minimum Residual Disease (MRD) Negative Remission Rate | 76 percentage of participants |
Secondary
Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants
Percentage of participants with MRD negative remission among CR participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CR: ≤5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \> 1.5 cm in GTD at baseline must have regressed to ≤ l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \> 1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set with CR were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: MRD Negative Remission Rate Among Complete Remission (CR) Participants | 97 percentage of participants |
Secondary
Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants
Percentage of participants with MRD negative remission among CRi participants was reported. MRD was assessed utilizing multicolor flow cytometry to detect residual cancerous cells with a sensitivity of 10\^-4. MRD negative remission was defined as MRD \< 10\^-4 threshold. CRi: ≤ 5% blasts by morphology in BM; ANC ≥ 1000/µL and Plt \< 100000/µL or ANC \< 1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size) and no new lesions. 95% CI was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set with CRi were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: MRD Negative Remission Rate Among Complete Remission With Incomplete Hematologic Recovery (CRi) Participants | 100 percentage of participants |
Secondary
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value
Grading categories are determined by CTCAE version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening.
Time frame: Up to 5 years
Population: Participants in Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Calcium | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Albumin | 5 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Glucose | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Alanine Aminotransferase | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Hematology: Hemoglobin | 42 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Hematology: Leukocytes | 54 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Hematology: Platelets | 46 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Hematology: Lymphocytes | 52 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Hematology: Neutrophils | 53 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Phosphate | 27 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Magnesium | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Sodium | 11 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Potassium | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Alkaline Phosphatase | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Aspartate Aminotransferase | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Bilirubin | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Creatinine | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Direct Bilirubin | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Decreased Parameter Value | Chemistry: Urate | 0 Participants |
Secondary
Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value
Grading categories are determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening.
Time frame: Up to 5 years
Population: Participants in Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Hematology: Lymphocytes | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Hematology: Leukocytes | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Hematology: Hemoglobin | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Hematology: Neutrophils | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Hematology: Platelets | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Creatinine | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Glucose | 13 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Aspartate Aminotransferase | 14 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Alanine Aminotransferase | 17 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Bilirubin | 5 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Alkaline Phosphatase | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Direct Bilirubin | 8 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Urate | 12 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Sodium | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Potassium | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Magnesium | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Calcium | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Albumin | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants Experiencing Laboratory Toxicity Grade 3 or Higher TEAEs Resulting From Increased Parameter Value | Chemistry: Phosphate | 0 Participants |
Secondary
Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale
The EQ-5D-5 levels(EQ-5D-5L)is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal.It is a self-reported questionnaire used to assess the overall health status of participant scoring 5 dimensions of health: mobility,self-care,usual activities,pain/discomfort and anxiety/depression.Each dimension has 5 levels:no problems,slight problems,moderate problems,severe problems,and extreme problems.EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by a formula that attaches values (called QOL utilities)to each of the levels in each dimension.EQ-5D Summary Index values range from -0.11(worst health) to 1.00(perfect health).This decision results in a 1-digit number that shows the level for that dimension. The digits for 5 dimensions can be combined to 5-digit number that show the participant's health.Higher scores of EQ-5D-5L indicate better health.
Time frame: Baseline, Day 28, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, and Month 24
Population: Participants in Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Mobility (Unable to walk) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Mobility (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Mobility (No problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Mobility (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Self-care (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Usual activities (Moderate problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Pain/Discomfort (No Problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Anxiety/Depression (Moderate problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Anxiety/Depression (Severe problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Anxiety/Depression (No problem) | 28 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Anxiety/Depression (No problem) | 18 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Mobility (No problem) | 39 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Mobility (Slight problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Mobility (Moderate problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Mobility (Severe problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Mobility (Unable to walk) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Mobility (No problem) | 19 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Mobility (Slight problem) | 10 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Mobility (Moderate problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Mobility (Severe problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Mobility (No problem) | 19 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Mobility (Slight problem) | 5 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Mobility (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Mobility (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Mobility (Unable to walk) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Mobility (No problem) | 16 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Mobility (Slight problem) | 6 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Mobility (Moderate problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Mobility (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Mobility (Unable to walk) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Mobility (No problem) | 8 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Mobility (Slight problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Mobility (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Mobility (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Mobility (Unable to walk) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Mobility (No problem) | 11 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Mobility (Slight problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Mobility (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Mobility (Unable to walk) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Mobility (Slight problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Mobility (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Mobility (Severity problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Mobility (Unable to walk) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Mobility (No problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Mobility (Slight problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Mobility (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Mobility (Unable to walk) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Mobility (No problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Mobility (Slight problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Mobility (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Mobility (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Mobility (Unable to Walk) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Self-care (No problem) | 44 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Self-care (Slight problem) | 5 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Self-care (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Self-care (Severe problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Self-care (No problem) | 31 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Self-care (Slight problem) | 6 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Self-care (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Self-care (Severe problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Self-care (Unable to wash or dress) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Self-care (No problem) | 23 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Self-care (Slight problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Self-care (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Self-care (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Self-care (No problem) | 23 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Self-care (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Self-care (Severe problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Self-care (No problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Self-care (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Self-care (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Self-care (Severe problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Self-care (No problem) | 14 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Self-care (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Self-care (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Self-care (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Self-care (No problem) | 10 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Self-care (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Self-care (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Self-care (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Self-care (No problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Self-care (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Self-care (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Self-care (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Self-care (No problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Self-care (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Self-care (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Self-care (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Self-care (Unable to wash or dress) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Usual activities (No problem) | 24 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Usual activities (Slight problem) | 14 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Usual activities (Moderate problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Usual activities (Severe problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Usual activities (Unable to do usual activities) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Usual activities (No problem) | 17 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Usual activities (Slight problem) | 13 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Usual activities (Moderate problem) | 8 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Usual activities (Severe problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Usual activities (Unable to do usual activities) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Usual activities (No problem) | 14 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Usual activities (Slight problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Usual activities (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Usual activities (Severe problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Usual activities (Unable to do usual activities) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Usual activities (No problem) | 17 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Usual activities (Slight problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Usual activities (Severe problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Usual activities (Unable to do usual activities) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Usual activities (No problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Usual activities (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Usual activities (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Usual activities (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Usual activities (Unable to do usual activities) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Usual activities (No problem) | 11 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Usual activities (Slight problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Usual activities (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Usual activities (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Usual activities (Unable to do usual activities) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Usual activities (No problem) | 8 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Usual activities (Slight problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Usual activities (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Usual activities (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Usual activities (Unable to do usual activities) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Usual activities (No problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Usual activities (Slight problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Usual activities (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Usual activities (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Usual activities (Unable to do usual activities) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Usual activities (No problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Usual activities (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Usual activities (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Usual activities (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Usual activities (Unable to do usual activities) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Pain/Discomfort (No Problem) | 23 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Pain/Discomfort (Slight Problem) | 16 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Pain/Discomfort (Moderate Problem) | 12 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Pain/Discomfort (No Problem) | 19 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Pain/Discomfort (Slight Problem) | 14 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Pain/Discomfort (Moderate Problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Pain/Discomfort (No Problem) | 11 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Pain/Discomfort (Slight Problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Pain/Discomfort (Moderate Problem) | 6 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Pain/Discomfort (No Problem) | 11 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Pain/Discomfort (Slight Problem) | 5 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Pain/Discomfort (Moderate Problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Pain/Discomfort (Severe Problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Pain/Discomfort (No Problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Pain/Discomfort (Slight Problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Pain/Discomfort (Moderate Problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Pain/Discomfort (No Problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Pain/Discomfort (Slight Problem) | 6 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Pain/Discomfort (Moderate Problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Pain/Discomfort (No Problem) | 6 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Pain/Discomfort (Slight Problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Pain/Discomfort (Moderate Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Pain/Discomfort (No Problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Pain/Discomfort (Slight Problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Pain/Discomfort (Moderate Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Pain/Discomfort (Slight Problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Pain/Discomfort (Moderate Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Pain/Discomfort (Severe Problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Pain/Discomfort (Extreme Pain or discomfort) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Anxiety/Depression (No problem) | 30 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Baseline: Anxiety/Depression (Slight problem) | 12 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Anxiety/Depression (Slight problem) | 11 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Anxiety/Depression (Moderate problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Day 28: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Anxiety/Depression (No problem) | 17 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Anxiety/Depression (Slight problem) | 6 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Anxiety/Depression (Moderate problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 3: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Anxiety/Depression (Slight problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Anxiety/Depression (Moderate problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 6: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Anxiety/Depression (No problem) | 9 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Anxiety/Depression (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Anxiety/Depression (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 9: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Anxiety/Depression (No problem) | 10 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Anxiety/Depression (Slight problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Anxiety/Depression (Moderate problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 12: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Anxiety/Depression (No problem) | 7 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Anxiety/Depression (Slight problem) | 2 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Anxiety/Depression (Moderate problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 15: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Anxiety/Depression (No problem) | 3 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Anxiety/Depression (Slight problem) | 1 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Anxiety/Depression (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 18: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Anxiety/Depression (No problem) | 4 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Anxiety/Depression (Slight problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Anxiety/Depression (Moderate problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Anxiety/Depression (Severe problem) | 0 Participants |
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Number of Participants With 5-Level European Quality of Life-5 Dimensions (EQ-5D-5L): Health Utility Index Scale | Month 24: Anxiety/Depression (Extreme Anxious or Depressed) | 0 Participants |
Secondary
Phase 2: OCR Rate (CR + CRi) Per Investigator Review
OCR rate: percentage of participants achieving CR+CRi. CR: ≤ 5% blasts by morphology in BM; ANC ≥1000/µL and Plt ≥ 100000/µL in PB; CNS EMD of CNS-1 (no detectable leukemia in CSF); Non-CNS EMD: if baseline EMD present (images must show CR), if no baseline EMD (then images not required), but if performed should show negative PET baseline, baseline lesions must show CR as disappearance of measurable and nonmeasurable nodal lesions (Nodal masses \>1.5 cm in GTD at baseline must have regressed to ≤l.5 cm GTD, nodes that were 1.1 to 1.5 cm \[long axis\] and \>1.0 cm \[short axis\] must have decreased to 1.0 cm in their short axis, spleen and/or liver must be normal size, if tested) and no new lesions. CRi: all CR criteria except in PB ANC ≥1000/µL and Plt \<100000/µL or ANC \<1000/µL and Plt ≥100000/µL. 95% CI was calculated by Clopper-Pearson method.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: OCR Rate (CR + CRi) Per Investigator Review | 72.7 percentage of participants |
Secondary
Phase 2: Overall Survival (OS)
OS was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Participants who had not died by the analysis data cutoff date were censored at their last contact date. KM estimates was used for analyses.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Overall Survival (OS) | 26.0 months |
Secondary
Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant after brexucabtagene autoleucel infusion, which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs included all AEs with onset on or after initiation of the brexucabtagene autoleucel infusion.
Time frame: Up to 5 years
Population: The Safety Analysis Set included all participants treated with any dose of brexucabtagene autoleucel.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 100 percentage of participants |
Secondary
Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT)
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 5 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Percentage of Participants With Allogeneic Stem Cell Transplant (Allo-SCT) | 20 percentage of participants |
Secondary
Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 2.7 years
Population: Participants in Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Percentage of Participants With Anti-KTE-X19 Antibodies | 7 percentage of participants |
Secondary
Phase 2: Relapse-free Survival (RFS)
RFS: time from brexucabtagene autoleucel infusion to date of disease relapse or death from any cause. Participants not meeting criteria for relapse by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who had not achieved a CR or CRi at analysis data cutoff were evaluated as an RFS event at Day 0. CR and CRi are defined in Outcome Measures 4 and 5. Relapse is defined in Outcome Measure 6. KM estimates was used for analyses.
Time frame: First infusion date of brexucabtagene autoleucel (Phase 2) up to 3.7 years
Population: Participants in mITT Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1: 2 x 10^6 Anti-CD19 CAR T Cells/kg | Phase 2: Relapse-free Survival (RFS) | 11.6 months |