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

NCT ID: NCT05244070

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-05-04

Brief Summary

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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).

Detailed Description

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Conditions

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Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986403 + Fludarabine + Cyclophosphamide

Group Type EXPERIMENTAL

BMS-986403

Intervention Type DRUG

Specified dose on specified days

Fludarabine

Intervention Type DRUG

Specified dose on specified days

Cyclophosphamide

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986403

Specified dose on specified days

Intervention Type DRUG

Fludarabine

Specified dose on specified days

Intervention Type DRUG

Cyclophosphamide

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0005

Birmingham, Alabama, United States

Site Status

Local Institution - 0016

Duarte, California, United States

Site Status

Local Institution - 0007

Boston, Massachusetts, United States

Site Status

Local Institution - 0026

Hackensack, New Jersey, United States

Site Status

Local Institution - 0009

Columbus, Ohio, United States

Site Status

Local Institution - 0002

Seattle, Washington, United States

Site Status

Local Institution - 0024

Barcelona, , Spain

Site Status

Local Institution

Madrid, , Spain

Site Status

Local Institution

Salamanca, , Spain

Site Status

Countries

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United States Spain

Related Links

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Other Identifiers

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2021-003274-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CA097-001

Identifier Type: -

Identifier Source: org_study_id

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