SAR445419

P1, N=0, Withdrawn, Duke University | N=12 --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 Withdrawn | Trial primary completion date: Sep 2025 --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P2, N=0, Withdrawn, Sanofi | N=107 --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 Withdrawn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

We will also exclude any patient requiring systemic corticosteroids with prednisone dose >10 mg or equivalent or who has KDS-1001 Donor specific antibodies (dsa) >5000 MFI units, or has KDS-1001 Donor anti-C1q positive. Exploratory analyses with immunophenotyping for NK cell chimerism and persistence will be done as feasible. Immune reconstitution studies or additional future research may be performed.

P1, N=12, Not yet recruiting, Lindsay Rein, MD | Trial completion date: Sep 2026 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2025

P1, N=30, Recruiting, Sumithira Vasu | N=44 --> 30 | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022

Kiadis K-NK003 cells are off-the-shelf NK cells from an universal donor expanded using PM21, proprietary membrane particles modified to express membrane bound IL-21 and 4-1bb ligand...Adult patients with chronic phase CML who have been on TKI therapy for at least 1 year prior to enrollment in the study will be eligible. Patients must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study and must be expected to remain on current TKI for the duration of the study.

Kiadis K-NK003 cells are off-the-shelf NK cells from an universal donor expanded using PM21, proprietary membrane particles modified to express membrane bound IL-21 and 4-1bb ligand...Adult patients with chronic phase CML who have been on TKI therapy for at least 1 year prior to enrollment in the study will be eligible. Patients must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study and must be expected to remain on current TKI for the duration of the study.

Kiadis K-NK003 cells are off-the-shelf NK cells from an universal donor expanded using PM21, proprietary membrane particles modified to express membrane bound IL-21 and 4-1bb ligand...Adult patients with chronic phase CML who have been on TKI therapy for at least 1 year prior to enrollment in the study will be eligible. Patients must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study and must be expected to remain on current TKI for the duration of the study.

Kiadis K-NK003 cells are off-the-shelf NK cells from an universal donor expanded using PM21, proprietary membrane particles modified to express membrane bound IL-21 and 4-1bb ligand...Adult patients with chronic phase CML who have been on TKI therapy for at least 1 year prior to enrollment in the study will be eligible. Patients must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study and must be expected to remain on current TKI for the duration of the study.

Kiadis K-NK003 cells are off-the-shelf NK cells from an universal donor expanded using PM21, proprietary membrane particles modified to express membrane bound IL-21 and 4-1bb ligand...Adult patients with chronic phase CML who have been on TKI therapy for at least 1 year prior to enrollment in the study will be eligible. Patients must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study and must be expected to remain on current TKI for the duration of the study.

Kiadis K-NK003 cells are off-the-shelf NK cells from a universal donor expanded using PM21, proprietary membrane particles modified to express membrane bound IL-21 and 4-1bb ligand...Patients must have been on their most recent TKI consistently for at least 6 months prior to enrollment on study and must be expected to remain on current TKI for the duration of the study. Patients with current accelerated or blast crisis phase disease will be excluded.