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]

Sponsor
Sanofi
Study ID
NCT05179603
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • THOR-707 — DRUG
    Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous infusion
  • Pembrolizumab — DRUG
    Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous infusion

Study Details

This 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.

Key Dates

Start date
Dec 7, 2021
Status verified
Dec 2025
Primary completion
Sep 14, 2023
Completion
Sep 6, 2024

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: Pegenzileukin 24 μg/kg + Pembrolizumab
    Participants with classic Hodgkin lymphoma (cHL) who were anti-programmed cell death-ligand 1 (PD-L1)-naïve and had received at least 2 or 3 lines of systemic therapy received pegenzileukin 24 microgram per kilogram (μg/kg) via intravenous (IV) infusion over 30 minutes on Day 1 of each cycle (each cycle is 21 days), along with pembrolizumab 200 milligram (mg) via 30 minutes IV infusion on Day 1 of each 3-week treatment cycle (each cycle is 21 days) as third-line or fourth-line (3/4L) therapy, until disease progression (PD), unacceptable adverse event (AE) or other full permanent discontinuation criteria was met or completion of Cycle 35.
  • Experimental: Cohort C1: (sub study 03) diffuse large B Cell lymphoma (DLBCL)
    Pegenzileukin administered every 2 weeks on Day 1 of each cycle (14 days per cycle) for up to 52 cycles.

Primary Outcome Measure

Complete Response Rate (CRR) [ Time Frame: From first dose of study treatment administration (Day 1) up to approximately 21 months ]

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