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NCT06090539 | RECRUITING | Relapsed/Refractory Non-Hodgkin Lymphoma

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

Bristol-Myers Squibb

Brief 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 relapsed/refractory non-Hodgkin Lymphoma.

Condition or disease

Relapsed/Refractory Non-Hodgkin Lymphoma

Intervention/treatment

BMS-986458

Rituximab

Glofitamab/Obinutuzumab

Mosunetuzumab

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 308 participants
Masking : NONE
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2023-12-29
Estimated Primary Completion Date : 2027-10-28
Estimated Study Completion Date : 2028-10-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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) 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.
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas

Location Details

NCT06090539

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

United States, Arizona

Local Institution - 0067

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

NOT YET RECRUITING

United States, Florida

Local Institution - 0027

Tampa, Florida, United States, 33612

NOT YET RECRUITING

United States, Kansas

Local Institution - 0014

Fairway, Kansas, United States, 66205

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

NOT YET RECRUITING

United States, Minnesota

Local Institution - 0066

Rochester, Minnesota, United States, 55905

RECRUITING

United States, New York

Northwell Health/ RJ Zuckerberg Cancer Center

Lake Success, New York, United States, 11042

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

NOT YET RECRUITING

United States, Pennsylvania

Local Institution - 0040

Pittsburgh, Pennsylvania, United States, 15232

NOT YET RECRUITING

France, Aquitaine

Local Institution - 0057

Bordeaux, Aquitaine, France, 33076

RECRUITING

France, Nord

Hospital Claude Huiez - Lille CHU

Lille, Nord, France, 59000

RECRUITING

France, Paris

Gustave Roussy

Villejuif, Paris, France, 94800

RECRUITING

France,

CHU Saint Eloi - Clinical hematology department

Montpellier, France, 34295

NOT YET RECRUITING

France,

Local Institution - 0058

Paris, France, 75010

RECRUITING

France,

Institut Claudius Regaud

Toulouse, France, 31059

RECRUITING

Germany, North Rhine-Westphalia

University Hospital Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany, 48149

RECRUITING

Germany, Saarland

University Clinic of the Saarland

Homburg, Saarland, Germany, 66424

RECRUITING

Germany, Saxony

University Hospital Leipzig

Leipzig, Saxony, Germany, 04103

RECRUITING

Germany,

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

RECRUITING

Netherlands, Limburg

Maastricht UMC+

Maastricht, Limburg, Netherlands, 6229 HX

RECRUITING

Netherlands,

University Medical Center Groningen

Groningen, Netherlands, 9713 GZ

RECRUITING

Spain, Andalusia

Virgen de la Victoria University Hospital

Malaga, Andalusia, Spain, 29010

RECRUITING

Spain, Barcelona [Barcelona]

Vall d'Hebron University Hospital

Barcelona, Barcelona [Barcelona], Spain, 08035

NOT YET RECRUITING

Spain, Madrid, community of

Local Institution - 0069

Madrid, Madrid, community of, Spain, 28009

RECRUITING

Spain, Navarra

Clinic University of Navarra

Pamplona, Navarra, Spain, 31008

RECRUITING

Spain,

Jiménez Díaz Foundation University Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

Salamanca University Hospital - Salamanca University Assistance Complex

Salamanca, Spain, 37007

RECRUITING

Switzerland, Ticino

Bellinzona and Valli Regional Hospital

Bellinzona, Ticino, Switzerland, 6500

RECRUITING

Switzerland,

University Hospital Basel

Basel, Switzerland, 4031

RECRUITING

Switzerland,

University hospital of Geneva (HUG)

Genetic, Switzerland, 1205