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NCT Number: NCT06090539

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0118, Antofagasta, AN, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986458

Drug

Specified dose on specified days.

Rituximab

Drug

Specified dose on specified days.

Other names: Truxima

Glofitamab/Obinutuzumab

Drug

Specified dose on specified days

Mosunetuzumab

Drug

Specified dose on specified days

Epcoritamab

Drug

Specified dose on specified days

Other names: GEN3013, Epkinly, Tepkinly

golcadomide

Drug

Specified dose on specified days

Other names: BMS-986369, CC-99282

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 2 years and 1 month

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 2 years and 1 month

  3. Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Time frame: Up to Day 28

  4. Number of participants with AEs leading to death

    Time frame: Up to 2 years and 1 month

  5. Number of participants with AEs leading to discontinuation

    Time frame: Up to 2 years and 1 month

  6. 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

    Part B2 Cohort B only

Secondary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Up to 4 months

  2. Time of maximum concentration (Tmax)

    Time frame: Up to 4 months

  3. Area under the plasma concentration-time curve within a dosing interval [AUC(TAU)]

    Time frame: Up to 4 months

  4. 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

  5. Number of participants with an overall response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma by investigator assessment

    Time frame: Up to 2 years

  6. Duration of response (DOR)

    Time frame: Up to 3 years

  7. Time to response (TTR)

    Time frame: Up to 3 years

  8. Progression-free survival (PFS)

    Time frame: Up to 3 years

  9. Overall survival (OS)

    Time frame: Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 19, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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