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A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

NCT06090539

RecruitingPhase 1, Phase 2

Sponsor: Bristol-Myers Squibb

Conditions: Relapsed/Refractory Non-Hodgkin Lymphoma

Interventions: BMS-986458, Rituximab, Glofitamab/Obinutuzumab, Mosunetuzumab, Epcoritamab

Countries: United States, Chile, China, France, Germany, Greece, Hong Kong, Italy

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (73)

Phoenix, Arizona, United States
Duarte, California, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
Lake Success, New York, United States
New York, New York, United States
New York, New York, United States
Providence, Rhode Island, United States
Antofagasta, AN, Chile
Santiago, Metropolitana de Santiago, Chile
Santiago, Santiago Metropolitan, Chile
Beijing, Beijing Municipality, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Nanchang, Jiangxi, China
Nanchang, Jiangxi, China
Shanghai, Shanghai Municipality, China
Hangzhou, Zhejiang, China
Bordeaux, Aquitaine, France
Lyon, Nan, France
Lille, Nord, France
Villejuif, Paris, France
Créteil, Val-de-Marne, France
Montpellier, France
Paris, France
Toulouse, France
Münster, North Rhine-Westphalia, Germany
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