A Phase 1/2 Study of BMS-986458 Alone and in Combination with Anti-lymphoma Agents in Relapsed/Refractory NH

Phase 1

Recruiting

• Conditions: on-Hodgkin Lymphomas; MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104; MedDRA version: 23.0Level: PTClassification code: 10029601Term: Non-Hodgkin's lymphoma refractory Class: 100000004864; MedDRA version: 23.0Level: PTClassification code: 10029600Term: Non-Hodgkin's lymphoma recurrent Class: 100000004864; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2023-506654-20-00
• Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Participants = 18 years of age with R/R NHL (including DLBCL [ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements], and FL):, For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment)., For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation., For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment., Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter) and must accept and follow pregnancy prevention plan.

Exclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status = 2, Inability to comply with listed restrictions, precautions and prohibited treatments, Prior CAR-T, Cereblon-modulating drug or radiotherapy = 4 weeks, systemic anticancer treatment = 5 half-lives or 4 weeks, allogeneic SCT = 6 months or autologous SCT = 3 months prior to study intervention initiation, Any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study; known or suspected central nervous system involvement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1/To assess the safety and tolerability of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with R/R NHL <br>2/To determine the RP2D(s) of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with R/R NHL.;Secondary Objective: To characterize the pharmacokinetic (PK) profile of BMS-986458 as a single agent and in combination with anti-lymphoma agents., To assess the preliminary efficacy of BMS-986458.;Primary end point(s): Incidence of adverse events (AEs), Serious adverse events (SAEs), AEs meeting protocol defined dose limiting toxicity (DLT) criteria, AEs leading to discontinuation, and death

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Summary measures of BMS-986458 PK parameters;Secondary end point(s):Overall response rate, Duration of response, Time to response, Progression free survival, Overall Survival