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

April 13, 2026 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

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

Study Locations

  • Chile
    • AN
      • Antofagasta, AN, Chile, 1240000
        • Not yet recruiting
        • Local Institution - 0118
        • Contact:
          • Site 0118
    • Metropolitana de Santiago
      • Santiago, Metropolitana de Santiago, Chile, 7580206
        • Not yet recruiting
        • Local Institution - 0105
        • Contact:
          • Site 0105
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8420383
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
  • China
      • Guangzhou, China, 510060
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Local Institution - 0088
        • Contact:
          • Site 0088
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • Local Institution - 0089
        • Contact:
          • Site 0089
  • France
      • Montpellier, France, 34295
        • Recruiting
        • CHU SAINT ELOI - Departement Hematologie Clinique
        • Contact:
          • Guillaume Cartron, Site 0005
          • Phone Number: +33675926918
      • Paris, France, 75010
        • Recruiting
        • Hopital Saint-Louis
        • Contact:
          • Catherine Thieblemont, Site 0058
          • Phone Number: 33142499236
      • Toulouse, France, 31059
        • Recruiting
        • Institut Claudius Regaud
        • Contact:
          • Loïc Ysebaert, Site 0002
          • Phone Number: 33531156351
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33076
        • Recruiting
        • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
        • Contact:
          • Fontanet Bijou, Site 0057
          • Phone Number: 33556333333
    • Nord
      • Lille, Nord, France, 59000
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Contact:
          • Franck Morschhauser, Site 0003
          • Phone Number: 33320445713
    • Paris
      • Villejuif, Paris, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
          • Vincent Ribrag, Site 0001
          • Phone Number: 33142114507
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94010
        • Recruiting
        • Henri Mondor Hospital
        • Contact:
          • François LEMONNIER, Site 0059
          • Phone Number: +33145178242
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin-Buch
        • Contact:
          • Snjezana Janjetovic, Site 0051
          • Phone Number: +49 30 9401-12104
      • Essen, Germany, 45147
        • Not yet recruiting
        • Local Institution - 0070
        • Contact:
          • Site 0070
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus
        • Contact:
          • Andrea Kerkhoff, Site 0049
          • Phone Number: +492518346010
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Recruiting
        • Universitaetsklinikum des Saarlandes
        • Contact:
          • Joerg Bittenbring, Site 0050
          • Phone Number: 4968411615000
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig
        • Contact:
          • Vladan Vucinic, Site 0029
          • Phone Number: 493419713841
  • Greece
      • Athens, Greece, 10676
        • Not yet recruiting
        • Local Institution - 0107
        • Contact:
          • Site 0107
      • Athens, Greece, 11 527
        • Not yet recruiting
        • Local Institution - 0102
        • Contact:
          • Site 0102
    • Achaḯa
      • Pátrai, Achaḯa, Greece, 26504
        • Not yet recruiting
        • Local Institution - 0103
        • Contact:
          • Site 0103
    • Evros
      • Alexandroupoli, Evros, Greece, 68100
        • Not yet recruiting
        • Local Institution - 0106
        • Contact:
          • Site 0106
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Local Institution - 0094
        • Contact:
          • Site 0094
      • Brescia, Italy, 25123
        • Not yet recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
      • Milan, Italy, 20132
        • Not yet recruiting
        • Local Institution - 0098
        • Contact:
          • Site 0098
      • Milan, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0113
        • Contact:
          • Site 0113
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Local Institution - 0112
        • Contact:
          • Site 0112
      • Ravenna, Italy, 48121
        • Not yet recruiting
        • Local Institution - 0111
        • Contact:
          • Site 0111
      • Roma, Italy, 00144
        • Not yet recruiting
        • Local Institution - 0115
        • Contact:
          • Site 0115
      • Roma, Italy, 00168
        • Not yet recruiting
        • Local Institution - 0110
        • Contact:
          • Site 0110
      • Verona, Italy, 37134
        • Not yet recruiting
        • Local Institution - 0097
        • Contact:
          • Site 0097
  • Japan
      • Fukuoka, Japan, 812-8582
        • Not yet recruiting
        • Local Institution - 0092
        • Contact:
          • Site 0092
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4668560
        • Not yet recruiting
        • Local Institution - 0090
        • Contact:
          • Site 0090
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Not yet recruiting
        • Local Institution - 0091
        • Contact:
          • Site 0091
    • Yamanashi
      • Chūō, Yamanashi, Japan, 4093898
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen
        • Contact:
          • Marcel Nijland, Site 0053
          • Phone Number: 050-3616161
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • Marjolein Van der Poel, Site 0052
          • Phone Number: +31433877026
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1981 HV
        • Not yet recruiting
        • Local Institution - 0121
        • Contact:
          • Site 0121
  • South Korea
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
  • Spain
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Daniel Morillo Giles, Site 0006
          • Phone Number: 349155048002218
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Alejandro Martin García-Sancho, Site 0019
          • Phone Number: 34923291100
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Antonio Rueda Dominguez, Site 0007
          • Phone Number: 607847416
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
          • Pau Abrisqueta Costa, Site 0041
          • Phone Number: 34932746000X4975
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Miguel Canales Albendea, Site 0018
          • Phone Number: 34 948 396 297
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
          • Fatime Krasniqi, Site 0032
          • Phone Number: 41612655074
      • Geneva, Switzerland, 1205
        • Recruiting
        • Hopitaux Universitaires de Geneve (HUG)
        • Contact:
          • Noemie Lang, Site 0048
          • Phone Number: +41795532406
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli
        • Contact:
          • Anastasios Stathis, Site 0033
          • Phone Number: 41918118931
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 0YD
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M20 4BX
        • Not yet recruiting
        • Local Institution - 0081
        • Contact:
          • Site 0081
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic in Arizona - Phoenix
        • Contact:
          • Javier Munoz, Site 0067
          • Phone Number: 000-000-0000
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
          • Avyakta Kallam, Site 0020
          • Phone Number: 626-219-9200
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Bijal Shah, Site 0027
          • Phone Number: 813-745-4294
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
          • David Qualls, Site 0044
          • Phone Number: 617-632-6844
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Yucai Wang, Site 0066
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Not yet recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
    • New York
      • Lake Success, New York, United States, 11042
        • Completed
        • Local Institution - 0047
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Jennifer Lue, Site 0046
          • Phone Number: 917-887-8514
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Not yet recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Local Institution - 0024
        • Contact:
          • Site 0024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A1
Single Agent
Drug: BMS-986458
Specified dose on specified days.
Experimental: Part A2
Combination Treatment
Drug: BMS-986458
Specified dose on specified days.
Drug: Rituximab
Specified dose on specified days.
Drug: Glofitamab/Obinutuzumab
Specified dose on specified days
Drug: Mosunetuzumab
Specified dose on specified days
Experimental: Part B1
Single Agent
Drug: BMS-986458
Specified dose on specified days.
Experimental: Part B2
Combination Treatment
Drug: BMS-986458
Specified dose on specified days.
Drug: Rituximab
Specified dose on specified days.
Drug: Glofitamab/Obinutuzumab
Specified dose on specified days
Drug: Mosunetuzumab
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with AEs leading to discontiunation
Time Frame: Up to 2 years and 1 month
Up to 2 years and 1 month
Number of participants with AEs leading to death
Time Frame: Up to 2 years and 1 month
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
Up to Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 3 years
Up to 3 years
Progression-free survival (PFS)
Time Frame: Up to 3 years
Up to 3 years
Duration of response (DOR)
Time Frame: Up to 3 years
Up to 3 years
Time to response (TTR)
Time Frame: Up to 3 years
Up to 3 years
Maximum concentration (Cmax)
Time Frame: Up to 4 months
Up to 4 months
Time of maximum concentration (Tmax)
Time Frame: Up to 4 months
Up to 4 months
Area under the plasma concentration-time curve within a dosing interval [AUC(TAU)]
Time Frame: Up to 4 months
Up to 4 months
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
Up to 2 years
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
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2023

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2028

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA123-1000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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