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)

• Status: Recruiting
• Trial end date: 2026-04-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• Participants must be ≥ 12 years of age, at the time of signing the informed consent

• Disease location amenable to tumor biopsy at baseline

• All participants must have a measurable disease

• Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:

to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment

and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.

• Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.

• Capable of giving signed informed consent

• Histologically or cytologically confirmed diagnosis of cHL, must have received at least two prior lines of systemic therapy for cHL, including at least one containing an anthracycline or brentuximab.

Exclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status of ≥2 (≥ 16 years old). Lansky Scale (< 16 years old) < 50%.

• Poor bone marrow reserve

• Poor organ function

• Participants with baseline SpO2 ≤92%.

• Lymphomatous involvement of the central nervous system.

• History of allogenic or solid organ transplant

• Last administration of prior antitumor therapy or any investigational treatment within 21 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 21 days.

• Has received prior IL-2-based anticancer treatment.

• Comorbidity requiring corticosteroid therapy

• Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP

• Severe or unstable cardiac condition within 6 months prior to starting study treatment

• Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years

• Known second malignancy either progressing or requiring active treatment within the last 3 years

• Receipt of a live or live attenuated virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines or SARS-CoV-2 vaccine that do not contain live virus are permitted.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.