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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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

Intervention / Treatment
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* Drug: BMS-986403
* Drug: Fludarabine
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986403 + Fludarabine + Cyclophosphamide<br> | Drug: BMS-986403<br>* Specified dose on specified days<br>Drug: Fludarabine<br>* Specified dose on specified days<br>Drug: Cyclophosphamide<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 response (DOR) |  | Up to 2 years after BMS-986403 infusion | 
| Duration of complete remission (DOCR) |  | Up to 2 years after BMS-986403 infusion | 
| Time to response (TTR) |  | Up to 2 years after BMS-986403 infusion | 
| Time to CR (TTCR) |  | Up to 2 years after BMS-986403 infusion | 
| Progression free survival (PFS) |  | Up to 2 years after BMS-986403 infusion | 
| Overall survival (OS) |  | 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 | 
| Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax) |  | Up to 2 years after BMS-986403 infusion | 
| Pharmacokinetics by PCR: Area under the curve (AUC) |  | Up to 2 years after BMS-986403 infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986403, Relapsed and/or Refractory, Small Lymphocytic Lymphoma (CLL), Chronic Lymphocytic Leukemia (SLL)