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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05244070
Recruitment Status : Recruiting
First Posted : February 17, 2022
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Drug: BMS-986403 Drug: Fludarabine Drug: Cyclophosphamide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : June 29, 2022
Estimated Primary Completion Date : June 17, 2027
Estimated Study Completion Date : June 17, 2027


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05244070


Contacts
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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
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United States, Alabama
Local Institution Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Site 0005         
United States, California
Local Institution Not yet recruiting
Duarte, California, United States, 91010
Contact: Site 0016         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Site 0007         
United States, New Jersey
John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Lori Leslie, Site 0026    201-341-5859      
United States, Ohio
University of Cincinnati Medical Center-University of Cincinnati Cancer Center Withdrawn
Cincinnati, Ohio, United States, 45267
Local Institution Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Site 0009         
United States, Texas
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0022         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98109-4433
Contact: Site 0002         
United States, Wisconsin
Local Institution Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Site 0015         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Site 0030         
Canada, Nova Scotia
Local Institution Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 0042         
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Site 0011         
France
Local Institution Not yet recruiting
Marseille, France, 13008
Contact: Site 0036         
Local Institution Not yet recruiting
Rennes, France, 35033
Contact: Site 0041         
Local Institution Not yet recruiting
Villejuif, France, 94800
Contact: Site 0028         
Italy
Local Institution Not yet recruiting
Bergamo, Italy, 24127
Contact: Site 0034         
Local Institution Not yet recruiting
Bologna, Italy, 40138
Contact: Site 0032         
Local Institution Not yet recruiting
Milano, Italy, 20132
Contact: Site 0033         
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 0024         
Local Institution Not yet recruiting
Madrid, Spain, 28040
Contact: Site 0017         
Local Institution Not yet recruiting
Salamanca, Spain, 37007
Contact: Site 0040         
United Kingdom
Local Institution Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Site 0037         
Local Institution Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Site 0021         
Local Institution Not yet recruiting
London, United Kingdom, NW1 2PG
Contact: Site 0035         
Local Institution Not yet recruiting
Manchester, United Kingdom, M20 4BX
Contact: Site 0014         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05244070    
Other Study ID Numbers: CA097-001
2021-003274-31 ( EudraCT Number )
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022

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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:
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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
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists