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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

Primary Purpose

Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-986403

Fludarabine

Cyclophosphamide

About this trial

This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic, B-Cell focused on measuring BMS-986403, Relapsed and/or Refractory, Small Lymphocytic Lymphoma (CLL), Chronic Lymphocytic Leukemia (SLL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-986403 + Fludarabine + Cyclophosphamide

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs)

Number of participants with serious adverse events (SAEs)

Number of participants with clinical laboratory abnormalities

Number of participants with dose-limiting toxicity (DLT)

Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period

Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period

Secondary Outcome Measures

Overall response rate (ORR)

Complete remission rate (CRR)

Duration of response (DOR)

Duration of complete remission (DOCR)

Time to response (TTR)

Time to CR (TTCR)

Progression free survival (PFS)

Overall survival (OS)

Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax)

Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax)

Pharmacokinetics by PCR: Area under the curve (AUC)

Full Information

NCT ID

NCT05244070

First Posted

February 8, 2022

Last Updated

July 14, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT05244070

Brief 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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Business objectives have changed.

Study Start Date

September 14, 2022 (Actual)

Primary Completion Date

May 4, 2023 (Actual)

Study Completion Date

May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-986403 + Fludarabine + Cyclophosphamide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-986403

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Number of participants with adverse events (AEs)

Time Frame