Status:
RECRUITING
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Relapsed/Refractory Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 degrad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 28 2028
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT06090539
Start Date
December 29 2023
End Date
October 28 2028
Last Update
December 8 2025
Active Locations (34)
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1
Local Institution - 0067
Phoenix, Arizona, United States, 85054
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
3
Local Institution - 0068
Jacksonville, Florida, United States, 32224
4
Local Institution - 0027
Tampa, Florida, United States, 33612