A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
NCT ID: NCT06090539
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
308 participants
INTERVENTIONAL
2023-12-29
2028-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part A1
Single Agent
BMS-986458
Specified dose on specified days.
Part A2
Combination Treatment
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
Part B1
Single Agent
BMS-986458
Specified dose on specified days.
Part B2
Combination Treatment
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0067
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Local Institution - 0068
Jacksonville, Florida, United States
Local Institution - 0027
Tampa, Florida, United States
Local Institution - 0014
Fairway, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution - 0066
Rochester, Minnesota, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Local Institution - 0040
Pittsburgh, Pennsylvania, United States
Local Institution - 0045
Providence, Rhode Island, United States
Local Institution - 0024
Milwaukee, Wisconsin, United States
Local Institution - 0057
Bordeaux, Aquitaine, France
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
Gustave Roussy
Villejuif, Paris, France
Henri Mondor Hospital
Créteil, Val-de-Marne, France
CHU SAINT ELOI - Departement Hematologie Clinique
Montpellier, , France
Local Institution - 0058
Paris, , France
Institut Claudius Regaud
Toulouse, , France
Universitätsklinikum Münster - Albert Schweitzer Campus
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes
Homburg, Saarland, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Helios Klinikum Berlin-Buch
Berlin, , Germany
Local Institution - 0070
Essen, , Germany
Maastricht UMC+
Maastricht, Limburg, Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0069
Madrid, Madrid, Comunidad de, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Ospedale Regionale Bellinzona e Valli
Bellinzona, Canton Ticino, Switzerland
University Hospital Basel
Basel, , Switzerland
Hopitaux Universitaires de Geneve (HUG)
Geneva, , Switzerland
Countries
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Central Contacts
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First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0067
Role: primary
Avyakta Kallam, Site 0020
Role: primary
Site 0068
Role: primary
Site 0027
Role: primary
Site 0014
Role: primary
David Qualls, Site 0044
Role: primary
Site 0066
Role: primary
Jonathan Kolitz, Site 0047
Role: primary
Jennifer Lue, Site 0046
Role: primary
Site 0040
Role: primary
Site 0045
Role: primary
Site 0024
Role: primary
Site 0057
Role: primary
Franck Morschhauser, Site 0003
Role: primary
Vincent Ribrag, Site 0001
Role: primary
François LEMONNIER, Site 0059
Role: primary
Guillaume Cartron, Site 0005
Role: primary
Site 0058
Role: primary
Loïc Ysebaert, Site 0002
Role: primary
Andrea Kerkhoff, Site 0049
Role: primary
Joerg Bittenbring, Site 0050
Role: primary
Vladan Vucinic, Site 0029
Role: primary
Snjezana Janjetovic, Site 0051
Role: primary
Site 0070
Role: primary
Marjolein Van der Poel, Site 0052
Role: primary
Marcel Nijland, Site 0053
Role: primary
Antonio Rueda Dominguez, Site 0007
Role: primary
Pau Abrisqueta Costa, Site 0041
Role: primary
Site 0069
Role: primary
Miguel Canales Albendea, Site 0018
Role: primary
Daniel Morillo Giles, Site 0006
Role: primary
Alejandro Martin García-Sancho, Site 0019
Role: primary
Anastasios Stathis, Site 0033
Role: primary
Fatime Krasniqi, Site 0032
Role: primary
Noemie Lang, Site 0048
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA123-1000
Identifier Type: -
Identifier Source: org_study_id
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