NCT03331198
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentJuno Therapeutics, a Subsidiary of Celgene
~320 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:JCAR017 (lisocabtagene maraleucel)JCAR017 (lisocabtagene maraleucel) + ibrutinibJCAR017 (lisocabtagene maraleucel) + venetoclax
At a glance
Recruiting sites
0 of 84 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 JCAR017 monotherapy arm: adverse events
Measured over Up to 48 months post treatment
+9 more outcomes measured
Conditions
Where it's being run
84 sites across 30 statesCalifornia8
New Jersey7
Pennsylvania6
Texas6
Michigan5
Illinois4
Massachusetts4
New York4
Study leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis of:
Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.
Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:
Eastern Cooperative Oncology Group performance status of ≤ 1
Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy
Adequate organ function, defined as:
Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax
Subjects in venetoclax + JCAR017 combination cohort must:
subjects in the venetoclax + JCAR017 combination must have hemoglobin \>=9 g/dL, absolute neutrophil count \>=500mm3 and platelets\>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry
Exclusion
Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
Subjects with Richter's transformation
Prior treatment with any gene therapy product
Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
Systemic fungal, bacterial, viral, or other infection that is not controlled
Presence of acute or extensive chronic graft versus host disease (GVHD)
History of any one of the following cardiovascular conditions within the past 6 months: 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
History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
Pregnant or nursing (lactating) women
Use of any of the following medications or treatments within the noted time prior to leukapheresis:
Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
Progressive vascular tumor invasion, thrombosis, or embolism
Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued
What this trial measures
- Phase 1 JCAR017 monotherapy arm: adverse eventsUp to 48 months post treatment
Proportion of subjects experiencing adverse events
- Phase 1 JCAR017 monotherapy arm: laboratory abnormalitiesUp to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
- Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse eventsUp to 48 months post treatment
Proportion of subjects experiencing adverse events
- Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalitiesUp to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
- Phase 1 JCAR017 and ibrutinib combination dose expansion therapy armThrough post treatment up to Month 48
Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines
- Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse eventsUp to 48 months post treatment
Proportion of subjects experiencing adverse events
- Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalitiesUp to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
- Phase 1 JCAR017 and venetoclax combination dose expansion therapy armThrough post treatment up to Month 48
Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines
- Phase 2 JCAR017 monotherapy expansion armThrough post treatment up to Month 48
Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines
- Phase 2 JCAR017 Double exposed monotherapy expansion arm: overall response rate (ORR)Up to approximately 24 months
ORR defined as the rate of complete response/remission (CR) \[including complete response/remission with incomplete marrow recovery (Cri)\] plus PR \[including nodular partial response (nPR)\] based on Independent Review Committee (IRC) assessment using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines