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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

  • Clinicaltrials.gov identifier

    NCT05244070

  • Recruitment Status

    Recruiting

  • First Posted

    February 17, 2022

  • Last update posted

    May 27, 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
Ottawa

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

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05244070 History of Changes
  • Other Study ID Numbers: CA097-001, 2021-003274-31
  • First Posted: February 17, 2022 Key Record Dates
  • Last Update Posted: May 27, 2022
  • Last Verified: May 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