Assessing BMS-986458 for treating relapsed non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of BMS-986458, a novel drug designed to target BCL6, both alone and in combination with standard anti-lymphoma treatments like Rituximab. It focuses on patients with relapsed or refractory non-Hodgkin lymphoma who have not responded to previous therapies. The study will measure drug levels, tolerability, and preliminary clinical activity to determine the potential benefits of this new treatment approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic in Arizona - Phoenix
  Phoenix, Arizona, United States Recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic in Rochester, Minnesota
  Rochester, Minnesota, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

+26 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.