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Assessing BMS-986458 for treating relapsed non-Hodgkin lymphoma

A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL)

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT06090539

This study is testing a new drug called BMS-986458 to see if it can help people with relapsed non-Hodgkin lymphoma when used alone or with standard treatments like Rituximab.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment308 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsrituximab, CAR-T, chemotherapy
Locations65 sites (Phoenix, Arizona and 64 other locations)
Trial IDNCT06090539 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory non-Hodgkin lymphoma who have undergone at least two prior lines of therapy.

Not a fit: Patients with non-relapsed non-Hodgkin lymphoma or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat non-Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar approaches targeting BCL6, indicating potential for success in this novel treatment strategy.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants ≥ 18 years of age with R/R NHL (including DLBCL \[ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements\], and FL):

  * For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment).
  * For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation.
  * For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment.
* 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.

Where this trial is running

Phoenix, Arizona and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed/Refractory Non-Hodgkin Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.