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

Recruiting now · Phase 1/Phase 2

Conditions studied: Relapsed/Refractory Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT06090539

Run by

Bristol-Myers Squibb

People needed

460

Starts

2023-12-29

Expected to finish

2028-10-28

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• Clinica Universidad de Navarra — Pamplona, Navarre, Spain (enrolling)
• Universitätsklinikum Leipzig — Leipzig, Saxony, Germany (enrolling)
• Maastricht UMC+ — Maastricht, Limburg, Netherlands (enrolling)
• Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [Barcelona], Spain (enrolling)
• Hospital General Universitario Gregorio Marañon — Madrid, Madrid, Comunidad de, Spain (enrolling)
• Universitätsklinikum Münster - Albert Schweitzer Campus — Münster, North Rhine-Westphalia, Germany (enrolling)
• Universitaetsklinikum des Saarlandes — Homburg, Saarland, Germany (enrolling)
• Helios Klinikum Berlin-Buch — Berlin, Germany (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States (enrolling)
• Hospital Universitario Virgen de la Victoria — Málaga, Andalusia, Spain (enrolling)
• Mayo Clinic in Arizona - Phoenix — Phoenix, Arizona, United States (enrolling)
• Beijing Cancer hospital — Beijing, Beijing Municipality, China (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Institut Claudius Regaud — Toulouse, France (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest — Bordeaux, Aquitaine, France (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Hopital Claude Huriez - CHU de Lille — Lille, Nord, France (enrolling)
• Gustave Roussy — Villejuif, Paris, France (enrolling)
• Henri Mondor Hospital — Créteil, Val-de-Marne, France (enrolling)
• CHU SAINT ELOI - Departement Hematologie Clinique — Montpellier, France (enrolling)
• Hôpital Saint-Louis — Paris, France (enrolling)
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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