A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06090539
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Relapsed/Refractory Non-Hodgkin Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BMS-986458 — DRUGSpecified dose on specified days.
- Rituximab — DRUGSpecified dose on specified days.
- Glofitamab/Obinutuzumab — DRUGSpecified dose on specified days
- Mosunetuzumab — DRUGSpecified dose on specified days
Study Details
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.
Key Dates
- Start date
- Dec 29, 2023
- Status verified
- Apr 2026
- Primary completion
- Oct 28, 2027
- Completion
- Oct 28, 2028
Study Design
- Enrollment
- 308 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Part A1Single Agent
- Experimental: Part A2Combination Treatment
- Experimental: Part B1Single Agent
- Experimental: Part B2Combination Treatment
Primary Outcome Measure
Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years and 1 month ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona | 85054 | Javier Munoz, Site 0067 000-000-0000 |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Avyakta Kallam, Site 0020 626-219-9200 |
| Local Institution - 0068 | Jacksonville | Florida | 32224 | Site 0068 |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Bijal Shah, Site 0027 813-745-4294 |
| Local Institution - 0014 | Fairway | Kansas | 66205 | Site 0014 |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | David Qualls, Site 0044 617-632-6844 |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | 55905 | Yucai Wang, Site 0066 |
| Local Institution - 0124 | Omaha | Nebraska | 68105 | Site 0124 |
| Local Institution - 0047 | Lake Success | New York | 11042 | - |
| Local Institution - 0037 | New York | New York | 10016 | Site 0037 |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Jennifer Lue, Site 0046 917-887-8514 |
| Local Institution - 0040 | Pittsburgh | Pennsylvania | 15232 | Site 0040 |
| Local Institution - 0045 | Providence | Rhode Island | 02903 | Site 0045 |
| Local Institution - 0024 | Milwaukee | Wisconsin | 53226 | Site 0024 |