A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)
Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 afte…
Interventions
- DrugBMS-986458
Specified dose on specified days.
- DrugRituximab
Specified dose on specified days.
- DrugGlofitamab/Obinutuzumab
Specified dose on specified days
- DrugMosunetuzumab
Specified dose on specified days
Locations (65)
- Mayo Clinic in Arizona - PhoenixPhoenix, Arizona
- City of Hope Comprehensive Cancer CenterDuarte, California
- Local Institution - 0068Jacksonville, Florida
- Moffitt Cancer CenterTampa, Florida
- Local Institution - 0014Fairway, Kansas
- Dana-Farber Cancer InstituteBoston, Massachusetts