Status:
TERMINATED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05244070
Start Date
September 14 2022
End Date
May 4 2023
Last Update
July 18 2023
Active Locations (9)
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1
Local Institution - 0005
Birmingham, Alabama, United States, 35249
2
Local Institution - 0016
Duarte, California, United States, 91010
3
Local Institution - 0007
Boston, Massachusetts, United States, 02114
4
Local Institution - 0026
Hackensack, New Jersey, United States, 07601