At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of CLL with indication for treatment and measurable disease, or SLL with CD19+ clonal B lymphocytes <5000/µL and biopsy-proven measurable disease
- ✓BTKi monotherapy cohorts: received and failed BTKi treatment OR deemed ineligible for BTKi
- ✓JCAR017 monotherapy high-risk: failed at least 2 lines of prior therapy
- ✓JCAR017 monotherapy standard-risk: failed at least 3 lines of prior therapy
- ✕Known active CNS involvement by malignancy (prior CNS disease eligible if treated ≥3 months prior with no symptomatic disease)
- ✕History of another primary malignancy not in remission ≥2 years (exceptions: nonmelanoma skin cancer, resected stage 1 solid tumor, localized prostate cancer, cervical carcinoma in situ, resected in situ breast cancer)
- ✕Richter's transformation
- ✕Prior treatment with any gene therapy product
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
In Brief
A Phase 2 clinical trial evaluating JCAR017 (lisocabtagene maraleucel), JCAR017 (lisocabtagene maraleucel) + ibrutinib, and 1 other intervention for Leukemia, Lymphocytic, Chronic, B-Cell and Lymphoma, Small Lymphocytic. Currently recruiting, targeting 320 participants across 86 sites in 2 countries.
Signals
Detailed Summary
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.
Study Details
Timeline
Interventions
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.