NCT06090539Recruiting
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, 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.
Inclusion criteria
• Participants ≥ 18 years of age with frontline or R/R NHL. • 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. • Other protocol-defined Inclusion/Exclusion criteria apply.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Chile, China, Greece, Hong Kong, Japan, Netherlands, South Korea, Spain, Turkey (Türkiye), United Kingdom
- Sponsor
- Bristol-Myers Squibb(Industry)
- Protocol no.
- CA123-1000
- Conditions
- Relapsed/Refractory Non-Hodgkin Lymphoma
- Interventions
- Drug
Treatments studied
- BMS-986458
- Rituximab
- Glofitamab/Obinutuzumab
- Mosunetuzumab
- Epcoritamab
- Golcadomide
Locations · 35
- Bellinzona, SwitzerlandOspedale Regionale Bellinzona e ValliRecruiting at this site
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
- Geneva, SwitzerlandHopitaux Universitaires de Geneve (HUG)Recruiting at this site
- Bordeaux, FranceInstitut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting at this site
- Lille, FranceHopital Claude Huriez - CHU de LilleRecruiting at this site
- Villejuif, FranceGustave RoussyRecruiting at this site
- Créteil, FranceHenri Mondor HospitalRecruiting at this site
- Montpellier, FranceCHU SAINT ELOI - Departement Hematologie CliniqueRecruiting at this site
- Paris, FranceHôpital Saint-LouisRecruiting at this site
- Toulouse, FranceInstitut Claudius RegaudRecruiting at this site
- Münster, GermanyUniversitätsklinikum Münster - Albert Schweitzer CampusRecruiting at this site
- Homburg, GermanyUniversitaetsklinikum des SaarlandesRecruiting at this site
- Leipzig, GermanyUniversitätsklinikum LeipzigRecruiting at this site
- Berlin, GermanyHelios Klinikum Berlin-BuchRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Phoenix, United StatesMayo Clinic in Arizona - PhoenixRecruiting at this site
- Duarte, United StatesCity of Hope Comprehensive Cancer CenterRecruiting at this site
- Tampa, United StatesMoffitt Cancer CenterRecruiting at this site
- Boston, United StatesDana-Farber Cancer InstituteRecruiting at this site
- Rochester, United StatesMayo Clinic in Rochester, MinnesotaRecruiting at this site
- New York, United StatesMemorial Sloan Kettering Cancer CenterRecruiting at this site
- Beijing, ChinaBeijing Cancer hospitalRecruiting at this site
- Guangzhou, ChinaSun Yat-sen University Cancer CenterRecruiting at this site
- Nanchang, ChinaThe First Affiliated Hospital of Nanchang UniversityRecruiting at this site
- Chuo-ku, JapanNational Cancer Center HospitalRecruiting at this site
- Chūō, JapanUniversity of Yamanashi HospitalRecruiting at this site
- Fukuoka, JapanKyushu University HospitalRecruiting at this site
- Maastricht, NetherlandsMaastricht UMC+Recruiting at this site
- Groningen, NetherlandsUniversity Medical Center GroningenRecruiting at this site
- Málaga, SpainHospital Universitario Virgen de la VictoriaRecruiting at this site
In total, worldwide, 35 of the 76 sites listed in the registry are recruiting; the other 41 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 23, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 5 more locations
Other identifiers
- 2023-506654-20 · other identifier
- U1111-1291-2654 · other identifier
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.