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Study of BMS-986458 for Relapsed/Refractory Non-Hodgkin Lymphoma

This study is looking at a new drug called BMS-986458, both by itself and with other anti-lymphoma medicines like Rituximab, Glofitamab/Obinutuzumab, Mosunetuzumab, and Epcoritamab. It's for people aged 18 or older who have non-Hodgkin lymphoma that has come back or hasn't responded to previous treatments (relapsed/refractory). The main goals are to see how safe the treatments are, how well your body handles them, and if they show early signs of helping to treat the cancer. The study plans to enroll about 460 participants. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 460 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 2 years and 1 month after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06090539

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~460 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:BMS-986458RituximabGlofitamab/ObinutuzumabMosunetuzumabEpcoritamabGolcadomide

At a glance

Recruiting sites
32 of 73 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to 2 years and 1 month
+5 more outcomes measured

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

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Where it's being run

73 sites across 52 states
Italy9
Turkey (Türkiye)4
New York3
France3
Florida2
Jiangxi2
Germany2
Greece2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with adverse events (AEs)Up to 2 years and 1 month
  • Number of participants with serious adverse events (SAEs)Up to 2 years and 1 month
  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteriaUp to Day 28
  • Number of participants with AEs leading to deathUp to 2 years and 1 month
  • Number of participants with AEs leading to discontinuationUp to 2 years and 1 month
  • Number of participants with a complete response rate (CRR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by Investigator assessmentUp to 2 years and 11 month

    Part B2 Cohort B only