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

NCT05244070 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CA097-0012021-003274-31
• Study Type: interventional
• Target: 5
• Locations: 2 countries
• Sites: 9

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).

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma

Keywords

BMS-986403; Relapsed and/or Refractory; Small Lymphocytic Lymphoma (CLL); Chronic Lymphocytic Leukemia (SLL)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (11)

• 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

Study Arms (1)

BMS-986403 + Fludarabine + Cyclophosphamide

EXPERIMENTAL

Drug: BMS-986403; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

BMS-986403 DRUG

Specified dose on specified days

BMS-986403 + Fludarabine + Cyclophosphamide

Fludarabine DRUG

Specified dose on specified days

BMS-986403 + Fludarabine + Cyclophosphamide

Cyclophosphamide DRUG

Specified dose on specified days

BMS-986403 + Fludarabine + Cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (9)

Local Institution - 0005

Birmingham, Alabama, 35249, United States

Location

Local Institution - 0016

Duarte, California, 91010, United States

Location

Local Institution - 0007

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0026

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0009

Columbus, Ohio, 43210, United States

Location

Local Institution - 0002

Seattle, Washington, 98109-4433, United States

Location

Local Institution - 0024

Barcelona, 08035, Spain

Location

Local Institution

Madrid, 28040, Spain

Location

Local Institution

Salamanca, 37007, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: September 14, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 4, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

US (6); ES (3)