Calendario›SNY›isatuximab SAR650984
isatuximab SAR650984
A Study of Isatuximab-based Therapy in Participants With Lymphoma
Ensayo de Sanofi en Linfoma.
Más ensayos de: Linfoma.
- Fase
- Fase 1/2
- Estado
- Interrumpido
- Participantes
- 58
- Centros
- 20
- Fin del objetivo primario
- nov 2022
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2018.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Study was stopped after interim analysis for all 4 cohorts with results either not fulfilling the pre-planned interim analysis criteria or fulfilling the criteria but as per sponsor decision. It was not due to any safety concern».
Qué mide
Number of Participants With Dose Limiting Toxicities (DLTs) (Cycle 1 (28 days)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: Phase 1 -To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory classic Hodgkin's lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL) or peripheral T-cell lymphoma (PTCL), and to confirm the recommended Phase 2 dose (RP2D). Phase 2 * Cohort A1 (anti-programmed cell death protein 1/ligand 1 \[PD-1/PD-L1\] naïve cHL): To assess the complete remission (CR) rate of isatuximab in combination with cemiplimab. * Cohort A2 (cHL progressing from PD-1/PD-L1), B (DLBCL) and C (PTCL): To assess the objective response rate (ORR) of isatuximab in combination with cemiplimab. Secondary Objectives: * To evaluate the safety of the RP2D of the combination of isatuximab with cemiplimab. * To evaluate the safety of the combination of isatuximab with cemiplimab and radiotherapy in participants with cHL. * To evaluate the immunogenicity of isatuximab and cemiplimab when given in combination. * To characterize the pharmacokinetic (PK) profile of isatuximab and cemiplimab when given in combination. * To assess overall efficacy of isatuximab in combination with cemiplimab and isatuximab in combination with cemiplimab and radiotherapy.
Más ensayos de SNY
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Avalglucosidase alfa · Mini-COMET | Fase 2 | En marcha, sin reclutar | sep 2019 (real) |
| Yellow fever vaccine | Fase 2 | En marcha, sin reclutar | may 2022 (real) |
| Yellow fever vaccine · VYF02 | Fase 2 | En marcha, sin reclutar | jun 2022 (real) |
| SAR441344 IV | Fase 2 | En marcha, sin reclutar | sep 2022 (real) |
| Meningococcal Polysaccharide | Fase 3 | En marcha, sin reclutar | mar 2023 (real) |
| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03769181), actualizada en sep 2025.