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
Phase 1
Terminated
- Conditions
- Leukemia, Lymphocytic, Chronic, B-CellLymphoma
- Interventions
- Registration Number
- NCT05244070
- Lead Sponsor
- Bristol-Myers Squibb
- 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 lymphoma (SLL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BMS-986403 + Fludarabine + Cyclophosphamide BMS-986403 - BMS-986403 + Fludarabine + Cyclophosphamide Cyclophosphamide - BMS-986403 + Fludarabine + Cyclophosphamide Fludarabine -
- Primary Outcome Measures
Name Time Method Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period Up to 2 years after BMS-986403 infusion Number of participants with adverse events (AEs) Up to 2 years after BMS-986403 infusion Number of participants with serious adverse events (SAEs) Up to 2 years after BMS-986403 infusion Number of participants with clinical laboratory abnormalities Up to 2 years after BMS-986403 infusion Number of participants with dose-limiting toxicity (DLT) Up to 2 years after BMS-986403 infusion Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period Up to 2 years after BMS-986403 infusion
- Secondary Outcome Measures
Name Time Method Time to response (TTR) Up to 2 years after BMS-986403 infusion Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax) Up to 2 years after BMS-986403 infusion Duration of response (DOR) Up to 2 years after BMS-986403 infusion Overall response rate (ORR) Up to 2 years after BMS-986403 infusion Complete remission rate (CRR) Up to 2 years after BMS-986403 infusion Duration of complete remission (DOCR) Up to 2 years after BMS-986403 infusion Pharmacokinetics by PCR: Area under the curve (AUC) Up to 2 years after BMS-986403 infusion Progression free survival (PFS) Up to 2 years after BMS-986403 infusion Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax) Up to 2 years after BMS-986403 infusion Time to CR (TTCR) Up to 2 years after BMS-986403 infusion Overall survival (OS) Up to 2 years after BMS-986403 infusion
Trial Locations
- Locations (8)
Local Institution - 0026
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0007
🇺🇸Boston, Massachusetts, United States
Local Institution - 0005
🇺🇸Birmingham, Alabama, United States
Local Institution - 0024
🇪🇸Barcelona, Spain
Local Institution
🇪🇸Salamanca, Spain
Local Institution - 0016
🇺🇸Duarte, California, United States
Local Institution - 0002
🇺🇸Seattle, Washington, United States
Local Institution - 0009
🇺🇸Columbus, Ohio, United States