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DRUG:

SAR445419

i
Other names: SAR445419, KDS-1001, K-NK003, K-NK-003, CD56bright/CD16bright NK-cell adoptive immunotherapy, FC21-NK cell therapy, KDS1001
Associations
Company:
Sanofi
Drug class:
NK cell stimulant
Related drugs:
Associations
6ms
Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML (clinicaltrials.gov)
P1, N=21, Recruiting, Sumithira Vasu | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date
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IL21 (Interleukin 21)
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cytarabine • fludarabine IV • SAR445419
7ms
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=7, Terminated, Sanofi | Trial completion date: Jan 2025 --> Mar 2024 | Active, not recruiting --> Terminated; Sponsor's decision
Trial completion date • Trial termination
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cytarabine • fludarabine IV • SAR445419
8ms
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (clinicaltrials.gov)
P2, N=0, Withdrawn, Sanofi | N=107 --> 0 | Trial completion date: Feb 2027 --> Oct 2027 | Not yet recruiting --> Withdrawn
Enrollment change • Trial completion date • Trial withdrawal
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SAR445419
9ms
Enrollment closed • Enrollment change
|
cytarabine • fludarabine IV • SAR445419
12ms
A Phase I, Single-Arm, Open Label, Dose Escalation, Multicenter Study of Off-the-Shelf Natural Killer (NK) Cells (SAR445419) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) (ASH 2023)
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.
Clinical • IO biomarker
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IL21 (Interleukin 21)
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cytarabine • prednisone • fludarabine IV • SAR445419
12ms
Trial primary completion date
|
cytarabine • fludarabine IV • SAR445419
1year
A Phase 2, Single-Arm, Multicohort, Open Label, Multicenter Trial of Off-the-Shelf Natural Killer Cells (SAR445419) in Patients with High-Risk Myeloid Malignancies Undergoing Allogeneic HSCT (ASH 2023)
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.
Clinical • P2 data
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IL21 (Interleukin 21)
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cyclophosphamide • SAR445419
1year
Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML (clinicaltrials.gov)
P1, N=21, Recruiting, Sumithira Vasu | N=30 --> 21 | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
Enrollment change • Trial completion date • Trial primary completion date
|
IL21 (Interleukin 21)
|
cytarabine • fludarabine IV • SAR445419
over1year
Enrollment open
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cytarabine • fludarabine IV • SAR445419
over1year
Trial initiation date
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SAR445419
2years
A Phase II Clinical Trial of "Off-the-Shelf" NK Cells with Allogeneic Stem Cell Transplantation to Decrease Disease Relapse in Patients with High-Risk Myeloid Malignancies (ASH 2022)
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.
Clinical • P2 data
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KIR2DS2 (Killer Cell Immunoglobulin Like Receptor, Two Ig Domains And Short Cytoplasmic Tail 2)
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prednisone • SAR445419
over2years
IIT PH1 KDS-1001 in Patients With CML (clinicaltrials.gov)
P1, N=12, Not yet recruiting, Lindsay Rein, MD | Trial completion date: Sep 2026 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
|
SAR445419
over2years
Ph1 Trial Test Safety of IL-21 NK Cells for Induction of R/R AML (clinicaltrials.gov)
P1, N=30, Recruiting, Sumithira Vasu | N=44 --> 30 | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
Enrollment change • Trial completion date • Trial primary completion date
|
IL21 (Interleukin 21)
|
cytarabine • fludarabine IV • SAR445419
almost4years
[VIRTUAL] A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy (TCT-ASTCT-CIBMTR 2021)
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.
Clinical • P1 data
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IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • GZMB (Granzyme B) • IL21 (Interleukin 21)
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IFNG elevation
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SAR445419
almost4years
[VIRTUAL] A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy (TCT-ASTCT-CIBMTR 2021)
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.
Clinical • P1 data
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • GZMB (Granzyme B) • IL21 (Interleukin 21)
|
IFNG elevation
|
SAR445419
almost4years
[VIRTUAL] A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy (TCT-ASTCT-CIBMTR 2021)
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.
Clinical • P1 data
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • GZMB (Granzyme B) • IL21 (Interleukin 21)
|
IFNG elevation
|
SAR445419
almost4years
[VIRTUAL] A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy (TCT-ASTCT-CIBMTR 2021)
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.
Clinical • P1 data
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • GZMB (Granzyme B) • IL21 (Interleukin 21)
|
IFNG elevation
|
SAR445419
almost4years
[VIRTUAL] A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy (TCT-ASTCT-CIBMTR 2021)
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.
Clinical • P1 data
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • GZMB (Granzyme B) • IL21 (Interleukin 21)
|
IFNG elevation
|
SAR445419
4years
[VIRTUAL] A Phase I Trial of Incorporating Natural Killer (K-NK) Cells for Patients with Chronic Myeloid Leukemia (CML) and Molecular Residual Disease after Tyrosine Kinase Inhibitor (TKI) Therapy (ASH 2020)
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.
Clinical • P1 data
|
IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2) • GZMB (Granzyme B) • IL21 (Interleukin 21)
|
SAR445419