AzTrials
AzTrials

Relapsed/Refractory Non-Hodgkin LymphomaPhase 1/2NCT06090539

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

A Phase 1/2 study testing BMS-986458, Rituximab and Glofitamab/Obinutuzumab in people with Relapsed/Refractory Non-Hodgkin Lymphoma, run by Bristol-Myers Squibb at 76 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Non-Hodgkin Lymphoma
What is being tested?
BMS-986458, Rituximab and Glofitamab/Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
76 sitesin 15 countries
Study dates
29 Dec 2023to 28 Oct 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

76 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

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

76 sites in 15 countries

United States11 sites, 10 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    David Qualls, Site 0044, 617-632-6844

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Alex Herrera, Site 0020, 626-218-2405

    Recruiting

  • Local Institution - 0068

    Jacksonville, Florida, 32224

    Site 0068

    Not yet recruiting

  • Local Institution - 0047

    Lake Success, New York, 11042

    Completed

  • Local Institution - 0037

    New York, New York, 10016

    Site 0037

    Not yet recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Jennifer Lue, Site 0046, 917-887-8514

    Recruiting

  • Local Institution - 0124

    Omaha, Nebraska, 68105

    Site 0124

    Not yet recruiting

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054

    Allison Rosenthal, Site 0067

    Recruiting

  • Local Institution - 0045

    Providence, Rhode Island, 02903

    Site 0045

    Not yet recruiting

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

    Yucai Wang, Site 0066

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Bijal Shah, Site 0027, 813-745-4294

    Recruiting

Other trials in United States

China10 sites, 10 recruiting

  • Beijing Cancer hospital

    Beijing, Beijing Municipality, 100142

    Yuqin Song, Site 0088, 13683398726

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

    Qingqing Cai, Site 0084, 13798101121

    Recruiting

  • Local Institution - 0128

    Hangzhou, Zhejiang, 310003

    Site 0128

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Fei Li, Site 0089, 13970038386

    Recruiting

  • Local Institution - 0130

    Nanchang, Jiangxi, 330029

    Site 0130

    Not yet recruiting

  • Local Institution - 0132

    Qingdao, Shandong, 266003

    Site 0132

    Not yet recruiting

  • Local Institution - 0131

    Shanghai, Shanghai Municipality, 0

    Site 0131

    Not yet recruiting

  • Local Institution - 0129

    Shenyang, Liaoning, 110001

    Site 0129

    Not yet recruiting

  • Local Institution - 0120

    Suzhou, Jiangsu, 215006

    Site 0120

    Not yet recruiting

  • Local Institution - 0087

    Zhengzhou, Henan, 450008

    Site 0087

    Not yet recruiting

Other trials in China

Italy9 sites, 9 recruiting

  • Local Institution - 0094

    Bologna, 40138

    Site 0094

    Not yet recruiting

  • Local Institution - 0116

    Brescia, 25123

    Site 0116

    Not yet recruiting

  • Local Institution - 0098

    Milan, 20132

    Site 0098

    Not yet recruiting

  • Local Institution - 0113

    Milan, 20133

    Site 0113

    Not yet recruiting

  • Local Institution - 0112

    Pisa, 56126

    Site 0112

    Not yet recruiting

  • Local Institution - 0111

    Ravenna, 48121

    Site 0111

    Not yet recruiting

  • Local Institution - 0115

    Roma, 00144

    Site 0115

    Not yet recruiting

  • Local Institution - 0110

    Roma, 00168

    Site 0110

    Not yet recruiting

  • Local Institution - 0097

    Verona, 37134

    Site 0097

    Not yet recruiting

Other trials in Italy

France8 sites, 8 recruiting

  • Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, Aquitaine, 33076

    Fontanet Bijou, Site 0057, 33556333333

    Recruiting

  • Henri Mondor Hospital

    Créteil, Val-de-Marne, 94010

    François LEMONNIER, Site 0059, +33145178242

    Recruiting

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord, 59000

    Franck Morschhauser, Site 0003, 33320445713

    Recruiting

  • Local Institution - 0125

    Lyon, Nan, 69373

    Site 0125

    Not yet recruiting

  • CHU SAINT ELOI - Departement Hematologie Clinique

    Montpellier, 34295

    Guillaume Cartron, Site 0005, +33675926918

    Recruiting

  • Hôpital Saint-Louis

    Paris, 75010

    Catherine Thieblemont, Site 0058, 33142499236

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Loïc Ysebaert, Site 0002, 33531156351

    Recruiting

  • Gustave Roussy

    Villejuif, Paris, 94800

    Vincent Ribrag, Site 0001, 33142114507

    Recruiting

Other trials in France

Spain6 sites, 6 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 08035

    Pau Abrisqueta Costa, Site 0041, 34932746000X4975

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009

    Mariana Bastos Oreiro, Site 0069, 34915868394

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Daniel Morillo Giles, Site 0006, 349155048002218

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

    Antonio Rueda Dominguez, Site 0007, 607847416

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Miguel Canales Albendea, Site 0018, 34 948 396 297

    Recruiting

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

    Alejandro Martin García-Sancho, Site 0019, 34923291100

    Recruiting

Other trials in Spain

Germany5 sites, 5 recruiting

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

    Snjezana Janjetovic, Site 0051, +49 30 9401-12104

    Recruiting

  • Universitaetsklinikum Essen

    Essen, 45122

    Bastian von Tresckow, Site 0070, +491631751277

    Recruiting

  • Universitaetsklinikum des Saarlandes

    Homburg, Saarland, 66424

    Joerg Bittenbring, Site 0050, 4968411615000

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

    Vladan Vucinic, Site 0029, 493419713841

    Recruiting

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149

    Evgenii Shumilov, Site 0049, +492518357765

    Recruiting

Other trials in Germany

Japan4 sites, 4 recruiting

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 4093898

    Ichiro Kawashima, Site 0086, 0552731111

    Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

    Wataru Munakata, Site 0091, 81335422511

    Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Kohta Miyawaki, Site 0092, 81926425230

    Recruiting

  • Local Institution - 0090

    Nagoya, Aichi-ken, 4668560

    Site 0090

    Not yet recruiting

Other trials in Japan

Turkey (Türkiye)4 sites, 4 recruiting

  • Local Institution - 0096

    Ankara, 06170

    Site 0096

    Not yet recruiting

  • Local Institution - 0101

    Ankara, 06620

    Site 0101

    Not yet recruiting

  • Local Institution - 0099

    Istanbul, 34365

    Site 0099

    Not yet recruiting

  • Local Institution - 0122

    Istanbul, 34899

    Site 0122

    Not yet recruiting

Other trials in Turkey (Türkiye)

Chile3 sites, 3 recruiting

  • Local Institution - 0118

    Antofagasta, AN, 1240000

    Site 0118

    Not yet recruiting

  • Local Institution - 0105

    Santiago, Metropolitana de Santiago, 7580206

    Site 0105

    Not yet recruiting

  • Local Institution - 0109

    Santiago, Santiago Metropolitan, 8420383

    Site 0109

    Not yet recruiting

Other trials in Chile

Greece3 sites, 3 recruiting

  • Local Institution - 0107

    Athens, 10676

    Site 0107

    Not yet recruiting

  • Local Institution - 0102

    Athens, 11 527

    Site 0102

    Not yet recruiting

  • Local Institution - 0103

    Pátrai, Achaḯa, 26504

    Site 0103

    Not yet recruiting

Other trials in Greece

Netherlands3 sites, 3 recruiting

  • Local Institution - 0121

    Amsterdam, North Holland, 1981 HV

    Site 0121

    Not yet recruiting

  • University Medical Center Groningen

    Groningen, 9713 GZ

    Marcel Nijland, Site 0053, 050-3616161

    Recruiting

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX

    Marjolein Van der Poel, Site 0052, +31433877026

    Recruiting

Other trials in Netherlands

South Korea3 sites, 3 recruiting

  • Local Institution - 0077

    Seoul, Seoul Teugbyeolsi, 06351

    Site 0077

    Not yet recruiting

  • Local Institution - 0123

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

    Site 0123

    Not yet recruiting

  • Local Institution - 0078

    Seoul, Seoul-teukbyeolsi, 05505

    Site 0078

    Not yet recruiting

Other trials in South Korea

Switzerland3 sites, 3 recruiting

  • University Hospital Basel

    Basel, 4031

    Fatime Krasniqi, Site 0032, 41612655074

    Recruiting

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, Canton Ticino, 6500

    Anastasios Stathis, Site 0033, 41918118931

    Recruiting

  • Hopitaux Universitaires de Geneve (HUG)

    Geneva, 1205

    Noemie Lang, Site 0048, +41795532406

    Recruiting

Other trials in Switzerland

United Kingdom3 sites, 3 recruiting

  • Local Institution - 0072

    Edinburgh, Midlothian, EH4 2XU

    Site 0072

    Not yet recruiting

  • Local Institution - 0081

    Manchester, Lancashire, M20 4BX

    Site 0081

    Not yet recruiting

  • Local Institution - 0071

    Southampton, Hampshire, SO16 0YD

    Site 0071

    Not yet recruiting

Other trials in United Kingdom

Hong Kong1 site, 1 recruiting

  • Local Institution - 0119

    Hong Kong, 0

    Site 0119

    Not yet recruiting

Other trials in Hong Kong

About this study

Official 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)

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.

Being tested
BMS-986458, Rituximab, Glofitamab/Obinutuzumab, Mosunetuzumab, Epcoritamab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986458Drug

    Specified dose on specified days.

  • RituximabDrug

    Also called Truxima

    Specified dose on specified days.

  • Glofitamab/ObinutuzumabDrug

    Specified dose on specified days

  • MosunetuzumabDrug

    Specified dose on specified days

  • EpcoritamabDrug

    Also called GEN3013, Epkinly, Tepkinly

    Specified dose on specified days

  • GolcadomideDrug

    Also called BMS-986369, CC-99282

    Specified dose on specified days

Study groups in NCT06090539
Study groupRoleWhat they receive
Part A1ExperimentalSingle Agent
Receives: Drug: BMS-986458
Part A2ExperimentalCombination Treatment
Receives: Drug: BMS-986458; Drug: Rituximab; Drug: Glofitamab/Obinutuzumab; Drug: Mosunetuzumab
Part B1ExperimentalSingle Agent
Receives: Drug: BMS-986458
Part B2ExperimentalCombination Treatment
Receives: Drug: BMS-986458; Drug: Rituximab; Drug: Glofitamab/Obinutuzumab; Drug: Epcoritamab; Drug: Golcadomide
Part B3ExperimentalSingle Agent
Receives: Drug: BMS-986458

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events (AEs)

    Measured: Up to 2 years and 1 month

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

    Measured: Up to 2 years and 1 month

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

    Measured: Up to Day 28

  4. Number of participants with AEs leading to death

    Measured: Up to 2 years and 1 month

  5. Number of participants with AEs leading to discontinuation

    Measured: 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

    Part B2 Cohort B only

    Measured: Up to 2 years and 11 month

Secondary outcomes (9)

  1. Maximum concentration (Cmax)

    Measured: Up to 4 months

  2. Time of maximum concentration (Tmax)

    Measured: Up to 4 months

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

    Measured: 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

    Measured: 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

    Measured: Up to 2 years

  6. Duration of response (DOR)

    Measured: Up to 3 years

  7. Time to response (TTR)

    Measured: Up to 3 years

  8. Progression-free survival (PFS)

    Measured: Up to 3 years

  9. Overall survival (OS)

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2023
  2. Study start29 Dec 2023
  3. Primary completion28 Oct 2027 (estimated)
  4. Study completion28 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06090539
Sponsor's protocol ID
CA123-1000
Other IDs
2023-506654-20, U1111-1291-2654, 2023
Status last verified
Oct 2026
First submitted
13 Oct 2023
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Mortensen DS, Shunatona HP, Holmberg-Douglas N, Rhodes J, Da Silva D, Gamez J, Groza M, Zhu J, Christoforou A, Johnson SA, Khambatta G, Narla RK, Nimje RY, Huang D, Dodd DS, Griffin J, Miseo G, Whitefield B, Weiss DR, Rader J, Kuzu E, Leisten J, Lai C, Shi L, Del Rosario J, Dalvie D, Rolfe M, Zapf CW, Belmont P, Alexander M, Bence N, Groocock L. Discovery of BMS-986458, a Potent and Selective B-Cell Lymphoma 6 Protein Ligand-Directed Degrader, for the Treatment of B-Cell Non-Hodgkin Lymphoma. J Med Chem. 2026 Feb 26;69(4):4424-4438. doi: 10.1021/acs.jmedchem.5c03123. Epub 2026 Feb 11.

    PubMed 41670385

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BMS-986458, Rituximab and Glofitamab/Obinutuzumab in people with Relapsed/Refractory Non-Hodgkin Lymphoma, run by Bristol-Myers Squibb at 76 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, China, Italy, France, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (AEs) (time frame: Up to 2 years and 1 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06090539, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in