Recruiting
Phase 1
Phase 2

BMS-986458 & Anti-Lymphoma Agents

Sponsor:

Bristol-Myers Squibb

Code:

NCT06090539

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986458

Rituximab

Glofitamab/Obinutuzumab

Mosunetuzumab

Epcoritamab

Study Details

Brief summary:

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.

Conditions

Relapsed/Refractory Non-Hodgkin Lymphoma

Study ID

NCT06090539

Start date

Dec 29, 2023

Status verified date

Aug, 2026

Completion date

Oct 28, 2028

Anticipated

Primary completion date

Oct 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A1

Single Agent

experimental: Part A2

Combination Treatment

experimental: Part B1

Single Agent

experimental: Part B2

Combination Treatment

experimental: Part B3

Single Agent

Interventions

BMS-986458

Specified dose on specified days.

Rituximab

Specified dose on specified days.

Glofitamab/Obinutuzumab

Specified dose on specified days

Mosunetuzumab

Specified dose on specified days

Epcoritamab

Specified dose on specified days

Golcadomide

Specified dose on specified days

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years and 1 month ]
  • Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years and 1 month ]
  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to Day 28 ]
  • Number of participants with AEs leading to death [ Time Frame: Up to 2 years and 1 month ]
  • Number of participants with AEs leading to discontinuation [ Time Frame: Up 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 assessment [ Time Frame: Up to 2 years and 11 month ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Mayo Clinic in Arizona - Phoenix

Recruiting

Phoenix, Arizona, United States, 85054

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Alex Herrera, Site 0020

626-218-2405

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Bijal Shah, Site 0027

813-745-4294

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

David Qualls, Site 0044

617-632-6844

Mayo Clinic in Rochester, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jennifer Lue, Site 0046

917-887-8514

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-18.