Non Hodgkin Lymphoma Clinical Trial

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

Summary

The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458 as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-Hodgkin Lymphoma.

View Eligibility Criteria

Eligibility Criteria

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)22 performance status ≥ 3.
Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.
Participants must not have prior CAR-T, Cereblon-modulating drug or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months or autologous SCT ≤ 3 months prior to study intervention initiation.
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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

273

Study ID:

NCT06090539

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 16 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Avyakta Kallam, Site 0020
Contact
626-219-9200
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Philippe Armand, Site 0044
Contact
617-632-2305
Local Institution - 0047
Lake Success New York, 11042, United States More Info
Site 0047
Contact
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Jennifer Lue, Site 0046
Contact
917-887-8514
Hopital Claude Huriez - CHU de Lille
Lille Nord, 59000, France More Info
Franck Morschhauser, Site 0003
Contact
33320445713
Gustave Roussy
Villejuif Paris, 94800, France More Info
Vincent Ribrag, Site 0001
Contact
33142114507
CHU SAINT ELOI-Département d'Hématologie Clinique
Montpellier , 34295, France More Info
Guillaume Cartron, Site 0005
Contact
+33675926918
Institut Claudius Regaud
Toulouse , 31059, France More Info
Loïc Ysebaert, Site 0002
Contact
33531156351
Maastricht UMC+
Maastricht Limburg, 6229 , Netherlands More Info
Marjolein Van der Poel, Site 0052
Contact
+31433877026
Local Institution - 0053
Groningen , 9713 , Netherlands More Info
Site 0053
Contact
Local Institution - 0007
Málaga Andalucía, 29010, Spain More Info
Site 0007
Contact
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain More Info
Miguel Canales Albendea, Site 0018
Contact
34 948 396 297
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain More Info
Raul Cordoba Mascuñano, Site 0006
Contact
+34649694829
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca , 37007, Spain More Info
Alejandro Martin García-Sancho, Site 0019
Contact
34923291100
Ospedale Regionale Bellinzona e Valli
Bellinzona Ticino, 6500, Switzerland More Info
Anastasios Stathis, Site 0033
Contact
41918118931
Hôpitaux Universitaire de Genève
Genève , 1211, Switzerland More Info
Noemie Lang, Site 0048
Contact
+41795532406

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

273

Study ID:

NCT06090539

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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