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

Stopped early · Phase 1

Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

In brief

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).

Key facts

Study ID

NCT05244070

Run by

Bristol-Myers Squibb

People needed

5

Starts

2022-09-14

Expected to finish

2023-05-04

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Local Institution - 0005 — Birmingham, Alabama, United States
• Local Institution - 0016 — Duarte, California, United States
• Local Institution - 0007 — Boston, Massachusetts, United States
• Local Institution - 0026 — Hackensack, New Jersey, United States
• Local Institution - 0009 — Columbus, Ohio, United States
• Local Institution - 0002 — Seattle, Washington, United States
• Local Institution - 0024 — Barcelona, Spain
• Local Institution — Madrid, Spain
• Local Institution — Salamanca, Spain

Full record on ClinicalTrials.gov

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