About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BMS-986458
- Rituximab
- Glofitamab/Obinutuzumab
- Mosunetuzumab
- Epcoritamab
- Golcadomide