Clinical Trial: NCT06090539
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Status:
RECRUITINGPhase:
Phase 1| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2026-09-14 |
Study Overview
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.
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)
Conditions
Relapsed/Refractory Non-Hodgkin Lymphoma
Intervention / Treatment
- Drug: BMS-986458
- Drug: Rituximab
- Drug: Glofitamab/Obinutuzumab
- Drug: Mosunetuzumab
- Drug: Epcoritamab
- Drug: Golcadomide
Other Study ID Numbers
- CA123-1000
- 2023-506654-20
- U1111-1291-2654
- 2023
Start Date (Actual)
2023-12-29
Primary Completion Date (Estimated)
2027-10-28
Study Completion Date (Estimated)
2028-10-28
Enrollment (Estimated)
460
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2026-09-14 |
Study Overview
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.
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)
Conditions
Relapsed/Refractory Non-Hodgkin Lymphoma
Intervention / Treatment
- Drug: BMS-986458
- Drug: Rituximab
- Drug: Glofitamab/Obinutuzumab
- Drug: Mosunetuzumab
- Drug: Epcoritamab
- Drug: Golcadomide
Other Study ID Numbers
- CA123-1000
- 2023-506654-20
- U1111-1291-2654
- 2023
Start Date (Actual)
2023-12-29
Primary Completion Date (Estimated)
2027-10-28
Study Completion Date (Estimated)
2028-10-28
Enrollment (Estimated)
460
Study Type
Interventional
Phase
Phase 1, Phase 2