SAR445419

P1, N=19, Active, not recruiting, Sumithira Vasu | Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2025

P1, N=0, Withdrawn, Duke University | N=12 --> 0 | Trial completion date: Sep 2027 --> Dec 2029 | Not yet recruiting --> Withdrawn | Trial primary completion date: Sep 2025 --> Dec 2027

P1, N=21, Recruiting, Sumithira Vasu | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=7, Terminated, Sanofi | Trial completion date: Jan 2025 --> Mar 2024 | Active, not recruiting --> Terminated; Sponsor's decision

P2, N=0, Withdrawn, Sanofi | N=107 --> 0 | Trial completion date: Feb 2027 --> Oct 2027 | Not yet recruiting --> Withdrawn

P1, N=7, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | N=12 --> 7

Eligible patients will be administered fludarabine, 30 mg/m 2/day and cytarabine, 2 g/m 2/day (Day -6 to Day -2) for 5 days followed by 6 doses of SAR'419 (intravenous) given thrice weekly over 2 weeks beginning on Day 1...Key exclusion criteria are participants with a second primary malignancy requiring active therapy (adjuvant hormonal therapy is allowed); with known acquired immunodeficiency syndrome or human immunodeficiency virus disease requiring antiretroviral treatment or having active hepatitis B or C infection, or symptomatic severe acute respiratory syndrome coronavirus 2 infection; and who are receiving >10 mg/day of oral prednisone or equivalent...All other safety analyses will be performed on the safety population using descriptive statistics. This study is actively recruiting at this time and is being conducted in the United States.

P1, N=12, Recruiting, Sanofi | Trial primary completion date: Oct 2023 --> Mar 2024

Prophylaxis for Graft-versus-host disease (GVHD) using cyclophosphamide, mycophenolate mofetil, and tacrolimus will start on Day +3. RFS will be reported as the percentage of patients who are relapse free and alive at 12 months from the date of HSCT and who received at least the first 2 planned doses of SAR'419. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 and will be summarized using descriptive statistics.

P1, N=21, Recruiting, Sumithira Vasu | N=30 --> 21 | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023

P1, N=12, Recruiting, Sanofi | Not yet recruiting --> Recruiting

P2, N=107, Not yet recruiting, Sanofi | Initiation date: May 2023 --> Feb 2024