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Clinical Trial Summary

This a phase 2 multi-cohort, un-controlled, non-randomized, open-label, multi-center study assessing the antitumor activity and safety of non-alpha interleukin (IL-2) SAR444245 in participants aged 12 years and older with relapsed or refractory B cell lymphoma. This study is structured as a master protocol with additional sub-studies (cohorts) to be added for the investigation of SAR444245 with other anticancer therapies. Substudy 1-Cohort A aims 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-programmed cell death-ligand (PD)-(L)1-naïve and have received at least 2 or 3 lines of systemic therapy.


Clinical Trial Description

The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 28 days, a treatment period [max 35 cycles or until PD], an end-of-treatment visit at least approximately 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visits 3 months after treatment discontinuation and every 3 months thereafter following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05179603
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email [email protected]
Status Recruiting
Phase Phase 2
Start date December 7, 2021
Completion date April 27, 2026

See also
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