Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 1/Phase 2
Bristol-Myers Squibb (Voir sur ClinicalTrials)
décembre 2023
octobre 2028
08 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Vincent RIBRAG | 12/06/2024 18:30:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU SAINT ELOI - Departement Hematologie Clinique - 34295 - Montpellier - France | Guillaume Cartron, Site 0005 | Contact (sur clinicalTrials) | |||
| Hopital Claude Huriez - CHU de Lille - 59000 - Lille - Nord - France | Franck Morschhauser, Site 0003 | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud - 31059 - Toulouse - France | Loïc Ysebaert, Site 0002 | Contact (sur clinicalTrials) | |||
| Local Institution - 0057 - 33076 - Bordeaux - Aquitaine - France | Site 0057 | Contact (sur clinicalTrials) | |||
| Local Institution - 0058 - 75010 - Paris - France | Site 0058 | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.