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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 1

Conditions

Lymphoma

Leukemia, Lymphocytic, Chronic, B-Cell

Treatments

Drug: BMS-986403

Drug: Cyclophosphamide

Drug: Fludarabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05244070

2021-003274-31 (EudraCT Number)

CA097-001

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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