Calendario›SNY›THOR-707
THOR-707
A Study of SAR444245 With or Without Other Anticancer Therapies for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Lymphoma (Master Protocol) [Pegathor Lymphoma 205]
Ensayo de Sanofi en Classic Hodgkin Lymphoma · Diffuse Large B-cell Lymphoma (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 14
- Centros
- 8
- Fin del objetivo primario
- sep 2023
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2021.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Early discontinuation based on strategic sponsor decision not driven by any safety concerns».
Qué mide
Complete Response Rate (CRR) (From first dose of study treatment administration (Day 1) up to approximately 21 months) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a phase 2 multi-cohort, un-controlled, non-randomized, open-label, multi-center study that assessed the antitumor activity and safety of non-alpha interleukin (IL-2) SAR444245 with or without other anticancer therapies in participants aged 12 years and older with relapsed or refractory B cell lymphoma. This study was structured as a master protocol with separate sub studies designed to investigate the use of SAR444245 either with or without other anticancer therapies for the treatment of relapsed or refractory B cell lymphoma. Substudy 1-Cohort A aimed to establish safety and preliminary anti-tumor activity for non-alpha interleukin (IL-2) SAR444245 combined with the anti-PD1 antibody, pembrolizumab in trial participants with classic Hodgkin lymphoma (cHL) who are anti-PD-(L)1-naive and have received at least 2 or 3 lines of systemic therapy. Substudy 3-Cohort C1 aims to establish safety and preliminary anti-tumor activity for SAR444245 as monotherapy in trial participants with diffuse large B-cell lymphoma (DLBCL). Trial participants in this study must have received at least 2 lines of systemic therapy and have either stable or progressive disease 1-3 months post Health Authority approved Chimeric Antigen Receptor T-cell (CAR-T) treatment when given as last systemic treatment prior to study enrollment.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05179603), actualizada en dic 2025.