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
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT05244070 Recruiting February 17, 2022 July 8, 2022

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: Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Intervention/treatment: Drug: BMS-986403
Drug: Fludarabine
Drug: Cyclophosphamide
Phase: Phase 1
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 40 participants
Allocation : Non-Randomized
Intervention Model : Single Group Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date: June 2022
Estimated Primary Completion Date: June 2027
Estimated Study Completion Date: June 2027

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: 1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
3. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 2 years after BMS-986403 infusion ]
4. Number of participants with dose-limiting toxicity (DLT) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
5. Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period [ Time Frame: Up to 2 years after BMS-986403 infusion ]
6. Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period [ Time Frame: Up to 2 years after BMS-986403 infusion ]
Secondary Outcome Measures: 1. Overall response rate (ORR) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
2. Complete remission rate (CRR) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
3. Duration of response (DOR) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
4. Duration of complete remission (DOCR) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
5. Time to response (TTR) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
6. Time to CR (TTCR) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
7. Progression free survival (PFS) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
8. Overall survival (OS) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
9. Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
10. Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax) [ Time Frame: Up to 2 years after BMS-986403 infusion ]
11. Pharmacokinetics by PCR: Area under the curve (AUC) [ Time Frame: Up to 2 years after BMS-986403 infusion ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations
United States, Alabama Local Institution Birmingham
United States, California Local Institution Duarte
United States, Massachusetts Local Institution Boston
United States, New Jersey John Theurer Cancer Center Hackensack
United States, Ohio University of Cincinnati Medical Center-University of Cincinnati Cancer Center Cincinnati
United States, Ohio Local Institution Columbus
United States, Texas Local Institution Houston
United States, Washington Local Institution Seattle
United States, Wisconsin Local Institution Milwaukee
Canada, Alberta Local Institution Calgary
Canada, Nova Scotia Local Institution Halifax
Canada, Ontario Local Institution Toronto
France Local Institution Marseille
France Local Institution Rennes
France Local Institution Villejuif
Italy Local Institution Bergamo
Italy Local Institution Bologna
Italy Local Institution Milano
Spain Local Institution Barcelona
Spain Local Institution Madrid
Spain Local Institution Salamanca
United Kingdom Local Institution Cambridge
United Kingdom Local Institution Leeds
United Kingdom Local Institution London
United Kingdom Local Institution Manchester
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT05244070     
Other Study ID Numbers : CA097-001, 2021-003274-31
First Posted : February 17, 2022
Last Update Posted : July 8, 2022
Last Verified : July 2022
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: BMS-986403
Relapsed and/or Refractory
Small Lymphocytic Lymphoma (CLL)
Chronic Lymphocytic Leukemia (SLL)
Additional relevant MeSH terms :
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell