A phase 3 study to assess the efficacy and safety of JCAR017, a CAR-T cell therapy, in adults with aggressive B-Cell non-Hodgkin lymphoma

A global randomized multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000929-32-SE

Enrollment

182

Registered

2018-06-04

Start date

2019-01-25

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant-eligible relapsed or refractory (R/R) aggressive B-cell Non Hodgkin Lymphoma (B-NHL) MedDRA version: 23.0 Level: LLT Classification code 10029593 Term: Non-Hodgkin's lymphoma NOS System Organ Class: 100000004864 MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Product Name: Lisocabtagene maraleucel Product Code: JCAR017 Pharmaceutical Form: Suspension for injection INN or Proposed INN: LISOCABTAGENE MARALEUCEL Current Sponsor code: JCAR017 Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is = 18 years and = 75 years of age at the time of signing the informed consent form (ICF). 2. ECOG performance status = 1. 3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]) primary mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B (FL3B). Enough tumor material must be available for confirmation by central pathology. 4. Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy 5. [18F] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion per Lugano criteria at screening (Deauville score 4 or 5). 6. Adequate organ function 7. Participants must agree to use effective contraception Please refer to protocol for full inclusion criteria. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 91 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 91

Exclusion criteria

Exclusion criteria: 1. Subjects not eligible for hematopoietic stem cell transplantation (HSCT). 2. Subjects planned to undergo allogeneic stem cell transplantation. 3. Subjects with primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation). 4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the subject has been free of the disease for = 2 years with the exception of the following noninvasive malignancies: - Basal cell carcinoma of the skin - Squamous cell carcinoma of the skin - Carcinoma in situ of the cervix - Carcinoma in situ of the breast - Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative. - Other completely resected stage 1 solid tumor with low risk for recurrence 5. Treatment with any prior gene therapy product 6. Subjects who have received previous CD19-targeted therapy. 7. Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded. 8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment. 9. Active autoimmune disease requiring immunosuppressive therapy. 10. History of any one of the following cardiovascular conditions within the past 6 months prior to signing the ICF: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease. 11. History or presence of clinically relevant central nervous system (CNS) pathology. 12. Pregnant or nursing (lactating) women. Please refer to protocol for full exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to compare the efficacy in subjects treated with JCAR017 versus subjects treated according to standard of care (SOC) defined as event-free survival (EFS).;Secondary Objective: The key secondary objectives are to compare the efficacy in subjects treated with JCAR017 versus subjects treated according to SOC defined as complete response rate (CRR), progression-free survival (PFS) and overall survival (OS). - To compare other parameters of efficacy, defined as duration of response (DoR), overall response rate (ORR), PFS on next line of treatment (PFS-2) - To compare efficacy rates (EFS, PFS, OS) at 6, 12, 24 and 36months after randomization - To compare the safety defined as type and frequency of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities - To compare the safety and efficacy in clinical, histological and molecular subgroups For other secondary objectives please refer to the protocol.;Primary end point(s): Event-free survival (EFS): Time from randomization to death from any cause, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR), or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first.;Timepoint(s) of evaluation of this end point: Up to 3 years post-randomization	—

Measure

Time frame

Main Objective: The primary objective of the study is to compare the efficacy in subjects treated with JCAR017 versus subjects treated according to standard of care (SOC) defined as event-free survival (EFS).;Secondary Objective: The key secondary objectives are to compare the efficacy in subjects treated with JCAR017 versus subjects treated according to SOC defined as complete response rate (CRR), progression-free survival (PFS) and overall survival (OS). - To compare other parameters of efficacy, defined as duration of response (DoR), overall response rate (ORR), PFS on next line of treatment (PFS-2) - To compare efficacy rates (EFS, PFS, OS) at 6, 12, 24 and 36months after randomization - To compare the safety defined as type and frequency of adverse events (AEs), serious adverse events (SAEs), and laboratory abnormalities - To compare the safety and efficacy in clinical, histological and molecular subgroups For other secondary objectives please refer to the protocol.;Primary end point(s): Event-free survival (EFS): Time from randomization to death from any cause, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR), or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first.;Timepoint(s) of evaluation of this end point: Up to 3 years post-randomization

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Secondary

Measure	Time frame
Secondary end point(s): 1. Complete response rate (CRR): Percentage of subjects achieving a complete response (CR). 2. Progression-free survival (PFS): Time from randomization to PD, or death from any cause, whichever occurs first. 3. Overall survival (OS): Time from randomization to time of death due to any cause. 4. Overall response rate (ORR): Percentage of subjects achieving an objective response of partial response (PR) or better. 5. Duration of response (DoR): Time from first response to disease progression, start of new antineoplastic therapy due to efficacy concerns or death from any cause. 6. PFS-2 on next line of treatment (PFS-2): Time from randomization to second objective disease progression or death from any cause, whichever is first. See protocol for all study endpoints;Timepoint(s) of evaluation of this end point: 1, 2, 4, 5, 6 - Up to 3 years post-randomization 3 - Up to last subject last visit	—

Measure

Time frame

Secondary end point(s): 1. Complete response rate (CRR): Percentage of subjects achieving a complete response (CR). 2. Progression-free survival (PFS): Time from randomization to PD, or death from any cause, whichever occurs first. 3. Overall survival (OS): Time from randomization to time of death due to any cause. 4. Overall response rate (ORR): Percentage of subjects achieving an objective response of partial response (PR) or better. 5. Duration of response (DoR): Time from first response to disease progression, start of new antineoplastic therapy due to efficacy concerns or death from any cause. 6. PFS-2 on next line of treatment (PFS-2): Time from randomization to second objective disease progression or death from any cause, whichever is first. See protocol for all study endpoints;Timepoint(s) of evaluation of this end point: 1, 2, 4, 5, 6 - Up to 3 years post-randomization 3 - Up to last subject last visit

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Countries

Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

Public ContactClinicalTrialDisclosure

Celgene Corporation

ClinicalTrialDisclosure@celgene.com+1913709 6862

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026