A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Purpose
The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy - Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 - Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure - Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)
Exclusion Criteria
- Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study - Systemic fungal, bacterial, viral, or other infection that is not controlled - Active autoimmune disease requiring immunosuppressive therapy - Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen Other protocol-defined inclusion/exclusion criteria apply
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental BMS-986403 + Fludarabine + Cyclophosphamide |
|
More Details
- Status
- Terminated
- Sponsor
- Bristol-Myers Squibb