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A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
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)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Participants ≥ 18 years of age with frontline or R/R NHL. * 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). * Participants must accept and follow pregnancy prevention plan. Exclusion Criteria: * Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2. * Participants with an inability to comply with listed restrictions, precautions and prohibited treatments. * Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation. * In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection. * Participants must not have 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. * Participants must not have known or suspected central nervous system involvement. * Other protocol-defined Inclusion/Exclusion criteria apply.
About the study
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.
What is being tested
- BMS-986458 (drug)
- Rituximab (drug)
- Glofitamab/Obinutuzumab (drug)
- Mosunetuzumab (drug)
- Epcoritamab (drug)
- Golcadomide (drug)
Sponsor: Bristol-Myers Squibb · Participants: 460 · Started: Dec 29, 2023
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT06090539
Locations in the U.S.
| Arizona | Mayo Clinic in Arizona - Phoenix, Phoenix |
| California | City of Hope Comprehensive Cancer Center, Duarte |
| Florida | Local Institution - 0068, Jacksonville (Not yet recruiting) Moffitt Cancer Center, Tampa |
| Massachusetts | Dana-Farber Cancer Institute, Boston |
| Minnesota | Mayo Clinic in Rochester, Minnesota, Rochester |
| Nebraska | Local Institution - 0124, Omaha (Not yet recruiting) |
| New York | Local Institution - 0037, New York (Not yet recruiting) Memorial Sloan Kettering Cancer Center, New York |
| Rhode Island | Local Institution - 0045, Providence (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.