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 Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BMS-986403 + Fludarabine + Cyclophosphamide
|
Drug: BMS-986403
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: Cyclophosphamide
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Birmingham | Alabama | United States | 35294 |
| 2 | Local Institution | Duarte | California | United States | 91010 |
| 3 | Local Institution | Boston | Massachusetts | United States | 02114 |
| 4 | John Theurer Cancer Center | Hackensack | New Jersey | United States | 07601 |
| 5 | University of Cincinnati Medical Center-University of Cincinnati Cancer Center | Cincinnati | Ohio | United States | 45267 |
| 6 | Local Institution | Columbus | Ohio | United States | 43210 |
| 7 | Local Institution | Houston | Texas | United States | 77030 |
| 8 | Local Institution | Seattle | Washington | United States | 98109-4433 |
| 9 | Local Institution | Milwaukee | Wisconsin | United States | 53226 |
| 10 | Local Institution | Calgary | Alberta | Canada | T2N 2T9 |
| 11 | Local Institution | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 12 | Local Institution | Toronto | Ontario | Canada | M5G 1Z5 |
| 13 | Local Institution | Marseille | France | 13008 | |
| 14 | Local Institution | Rennes | France | 35033 | |
| 15 | Local Institution | Villejuif | France | 94800 | |
| 16 | Local Institution | Bergamo | Italy | 24127 | |
| 17 | Local Institution | Bologna | Italy | 40138 | |
| 18 | Local Institution | Milano | Italy | 20132 | |
| 19 | Local Institution | Barcelona | Spain | 08035 | |
| 20 | Local Institution | Madrid | Spain | 28040 | |
| 21 | Local Institution | Salamanca | Spain | 37007 | |
| 22 | Local Institution | Cambridge | United Kingdom | CB2 0QQ | |
| 23 | Local Institution | Leeds | United Kingdom | LS9 7TF | |
| 24 | Local Institution | London | United Kingdom | NW1 2PG | |
| 25 | Local Institution | Manchester | United Kingdom | M20 4BX |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- CA097-001
- 2021-003274-31