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JCAR017

Phase 3

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 5, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment635
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03575351A Study 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 LymphomasPHASE3 COMPLETED 184Oct 23, 2018Oct 23, 2023Aug 3, 202554 United States, Belgium +10
NCT04245839A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)PHASE2 ACTIVE NOT_RECRUITING 276Jul 14, 2020Sep 30, 2031Nov 5, 202549 United States, Austria +8
NCT03484702Trial to Determine the Efficacy and Safety of JCAR017 in Adult Participants With Aggressive B-Cell Non-Hodgkin LymphomaPHASE2 COMPLETED 113Jun 5, 2018Dec 15, 2023Dec 27, 202420 Austria, Belgium +9
NCT03310619A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell MalignanciesPHASE1 COMPLETED 62Dec 20, 2017Feb 15, 2023Apr 4, 20249 United States
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Study Endpoints
Primary Endpoints
Event-free Survival (EFS) Per Independent Review Committee (IRC)
From randomization to death from any cause, PD, failure to achieve CR or PR by 9 weeks post randomization, or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first (Up to 36 months)

Time from randomization to death, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR) by 9 weeks or start of new antineoplastic therapy, whichever occurs first. CR: Target nodes masses must regress to ≤ 1.5cm in LDi, no extralymphatic sites, no new lesions. PR: ≥ 50% decrease in sum of diameters of up to 6 target nodes and extranodal sites, no new lesions, spleen must have regressed \> 50% in length. PD: LDi \> 1.5cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2cm, 1.0cm for lesions \> 2cm. Complete metabolic response: Lymph nodes score 1, 2, 3 with/without residual mass on 5-point scale, no new lesions, no FDG-avid disease. Partial metabolic response: Lymph nodes score 4 or 5, reduced uptake from baseline, no new lesions, residual uptake higher than normal, reduced from baseline. Progressive metabolic disease: Score 4 or 5 with an increase in uptake intensity from baseline and/or new FDG-avid.

Overall Response Rate (ORR)
Up to 60 months

Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 60 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"

Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3
From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

Overall response rate (ORR) by Independent Review Committee (Cohorts 1, 2, 3). ORR is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: No * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: No * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: No * Organ enlargement: Spleen length decreased \> 50% * New lesions: No

Overall Response Rate (ORR) Per Investigator in Cohort 4
From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

Overall response rate (ORR) is the percent of participants with best overall response of complete response (CR) or partial response (PR). Complete response via PET-CT: * Lymph nodes/extralymphatic: Score 1, 2, 3a with/without residual mass on 5-point scale * New lesions: No * Bone marrow: No FDG-avid disease Complete response via CT scan: * Lymph nodes/extralymphatic: Target nodes/nodal masses ≤ 1.5 cm longest transverse diameter. * Nonmeasured lesion: None * New lesions: No * Bone marrow: Normal Partial response via PET-CT: * Lymph nodes/extralymphatic: Score 4, 5b, reduced uptake from baseline * New lesions: None * Bone marrow: Residual uptake higher than normal, reduced from baseline Partial response via CT scan: * Lymph nodes/extralymphatic: 50% decrease in sum of diameters of \<= 6 target measurable nodes/extranodal sites * Nonmeasured lesion: None/normal * Organ enlargement: Spleen length decreased \> 50% * New lesions: No

Overall Response Rate (ORR) Per Investigator in Cohort 5
From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)

Overall response rate (ORR) determined by Investigator assessment after JCAR017 infusion. The ORR is the percent of participants with best overall response (BOR) of either complete response (CR), complete response unconfirmed (Cru) or partial response (PR). Complete response (CR): * Brain imaging: No contrast enhancement * Corticosteroid dose: None * Eye examination: Normal * Cerebrospinal fluid cytology: Negative Complete response unconfirmed (CRu): * Brain imaging: No contrast enhancement, Minimal abnormality * Corticosteroid dose: Any * Eye examination: Normal, minor RPE abnormality * Cerebrospinal fluid cytology: Negative Partial response (PR): * Brain imaging: 50% decrease in enhancing tumor, no contrast enhancement. * Corticosteroid dose: Irrelevant * Eye examination: Minor RPE abnormality, decrease in vitreous cells or retinal infiltrate. * Cerebrospinal fluid cytology: Negative, persistent or suspicious

Number of Participants With Adverse Events in Cohort 7
From leukapheresis to end of study (up to approximately 63 months)

An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

Number of Participants With Serious Adverse Events (SAEs) in Cohort 7
From leukapheresis to end of study (up to approximately 63 months)

A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that: * Results in death; * Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE); * Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay). * Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions); * Is a congenital anomaly/birth defect; * Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.

Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7
At Baseline and Day 29 after JCAR017 infusion

JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).

Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7
At Baseline and Day 29 after JCAR017 infusion

JCAR017 treatment-emergent laboratory abnormalities are defined as an abnormality that, compared to baseline, worsens by at least one grade after JCAR017 infusion. The baseline value is defined as the last available recorded value on or prior to the date of JCAR017 infusion. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), Grade 5 (Death).

Number of Participants With Dose-Limiting Toxicity (DLT)
From first dose of the combination agent until 1 month (28 days) after JCAR017 infusion (pre- JCAR017 cohort) or from JCAR017 infusion until 1 month (28 days) after the first dose of combination agent (post-JCAR017 cohort)

Participants enrolled in Phase 1 are considered evaluable for DLTs if they received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and completed the specified DLT evaluation period or if they have received an infusion of conforming JCAR017 cell product and at least one dose of the combination agent and experience a DLT during the DLT evaluation period.

Complete Response Rate (CRR)
At 3 and 6 months post-JCAR017 infusion.

Percentage of participants achieving a complete response (CR). CR is complete radiologic response (CRR) and complete metabolic response (CMR). CR was measured using CT and PET and assessed for the presence of index and non-index lesions, spleen size, and the absence of new lesions or diseased bone marrow. To be considered as having CRR participants had to have all of the following: * Index lesions - longest transverse diameter of nodal lesions ≤ 1.5 cm and the absence of extranodal disease. * Non-index lesions - the absence of non-index lesions. * Spleen size \<13 cm * The absence of new lesions * Normal bone marrow assessment To be considered as having CMR participants had to have all of the following: * A score of 1, 2, or 3 with or without residual mass on 5-PS for index and non-index lesions. * The absence of new lesions * No evidence of FDG-avid disease in marrow and a normal bone marrow assessment

Secondary Endpoints
Complete Response Rate (CRR)
From randomization up to 3 years post randomization (Up to 36 months)
Number of Participants With Complete Response (CR)
From randomization up to 3 years post randomization (Up to 36 months)
Progression-free Survival (PFS)
From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A - Standard of Care (SOC)ACTIVE_COMPARATORSubjects should receive SOC (R-DHAP, R-ICE or R-GDP) followed by HDCT (BEAM) and HSCT. Standard of care regimen will be administered as per investigator decision.
Arm B - JCAR017EXPERIMENTALLymphodepleting chemotherapy with intravenous (IV) fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide IV (300 mg/m2/day for 3 days) (flu/cy) concurrently followed by JCAR017 infusion.
Administration of JCAR017EXPERIMENTAL* Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents. * JCAR017 will be infused on Day 1 at a target dose of 100 × 10\^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Arm A: JCAR017 in combination with DurvalumabEXPERIMENTALJCAR017 will be administered at a single flat dose of 50 x 10\^6 CAR+T cells or 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules
Arm B: JCAR017 in combination with CC-122EXPERIMENTALThis arm will test JCAR017 in combination with the CC-122. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses
Arm C: JCAR017 in combination with CC-220EXPERIMENTALThis arm will test JCAR017 in combination with CC-220. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses
Arm D: JCAR017 in combination with IbrutinibEXPERIMENTALThis arm will test JCAR017 in combination with ibrutinib. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at a fixed dose of 420 mg daily
Arm E: JCAR017 in combination with relatlimab and/or nivolumabEXPERIMENTALThis arm will test JCAR017 in combination with relatlimab and/or nivolumab in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules
Arm F: JCAR017 in combination with CC-99282EXPERIMENTALThis arm will test JCAR017 in combination with CC-99282 in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10\^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules.
Interventions
NameTypeDescription
Standard of CareDRUGStandard of Care
JCAR017GENETICJCAR017
FludarabineDRUGFludarabine
CyclophosphamideDRUGCyclophosphamide
DurvalumabDRUGAnti-PD-L1
CC-122DRUGPleiotropic Pathway Modifier
IbrutinibDRUGIbrutinib
CC-220DRUGCC-220
RelatlimabDRUGRelatlimab
NivolumabDRUGNivolumab
CC-99282DRUGCC-99282
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: 1. Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. 3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed indolent NHL), h...

Countries:United StatesBelgiumFinlandFranceGermanyItalyJapanNetherlandsSpainSwedenSwitzerlandUnited KingdomAustriaCanada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04245839primaryCompletionDate: changed
LOWMay 24, 2026NCT04245839studyFirstPostDate: changed