Acute Myeloid LeukaemiaPhase 1NCT05712278
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing SAR445419, fludarabine and cytarabine in people with Acute Myeloid Leukaemia, run by Sanofi at 3 sites in United States.
Trial summary
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and cytarabine conditioning for the treatment of relapsed or refractory acute myeloid leukemia (R/R… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukaemia
- What is being tested?
- SAR445419, fludarabine and cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2023to 12 Mar 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 years of age inclusive
- Participants with confirmed diagnosis of relapsed or primary refractory acute myeloid leukemia (AML), according to World Health Organization (WHO) classification, including:
- Participants with relapsed AML after allogeneic stem cells transplantation, including those who have received donor lymphocyte infusions,
- Isolated central nervous system (CNS) or extramedullary disease,
- At least 1 prior line of therapy which includes chemotherapy, hypomethylating agents, venetoclax or targeted therapy.
- Participants with a weight ≥42 kg.
Who cannot join
- Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
- Known acquired immunodeficiency syndrome (AIDS-related illnesses) or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or having active hepatitis B or C infection, or symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Pregnant or breast-feeding women, female participants of childbearing potential, and male participants with female partners of childbearing potential who are not willing to avoid pregnancy by using a highly effective method of contraception (2 barrier method or 1 barrier method with a spermicide, intrauterine device, or hormonal contraception with inhibition of ovulation, for 2 weeks prior to the first dose of SAR445419, during treatment, and 6 months after the last dose of fludarabine). A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile.
- History of solid organ transplant, including corneal transplant.
- Receiving at the time of first SAR445419 administration corticosteroid as a concomitant medication with corticosteroid dose >10 mg/day of oral prednisone or the equivalent, except steroid inhaler, nasal spray, or ophthalmic solution
- Known contraindication to any of the non-investigational medicinal products (NIMPs) (fludarabine, cytarabine, acetaminophen and diphenhydramine).
- Concurrent treatment with other investigational drugs
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
~MD Anderson Cancer Center Site Number : 8400002
Houston, Texas, 77030
University of Nebraska Medical Center Site Number : 8400003
Omaha, Nebraska, 68198-2168
Albert Einstein College of Medicine Site Number : 8400001
The Bronx, New York, 10461
About this study
Official title: A Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and cytarabine conditioning for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). Adult participants with R/R AML will be eligible for treatment.
The study is intended to assess the candidate dose(s) by the occurrence of dose-limiting toxicity (DLT) from start of chemotherapy until 28 days after the first administration of SAR445419.
Read more
The duration of the study for a participant will include:
- Screening period up to 21 days prior to initiating chemotherapy,
- Treatment period of 5 days chemotherapy followed by SAR445419 administered for 2 weeks and end of treatment visit 56 days after first SAR445419 administration,
- Survival follow-up period up to 1 year after the last participant has started treatment with SAR445419.
Read the detailed description
Participants will be followed for 28 days (for DLT evaluations) after administration of the first SAR445419 dose (Day 1) for the primary endpoint and for 1 year after the first SAR445419 dose for selected secondary endpoints.
- Conditions
- Acute Myeloid Leukaemia
- Being tested
- SAR445419, fludarabine, cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR445419Drug
Cell suspension, by intraveneous (IV) injection
fludarabineDrug
Also called fludara
Solution for injection , by IV injection
cytarabineDrug
Also called cytosar-U
Solution for injection, by IV injection
| Study group | Role | What they receive |
|---|---|---|
| SAR445419 | Experimental | Treatment consists of chemotherapy with fludarabine 30mg/m2/day and cytarabine 2g/m2/day administered for 5 days (Day -6 to Day -2), followed by 6 doses of SAR445419 given thrice weekly for 2 weeks beginning Day 1. Receives: Drug: SAR445419; Drug: fludarabine; Drug: cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting (DLT) toxicity
Measured: from Day 1 to Day 28
Incidence of DLT from start of chemotherapy
Measured: From Day -6 to Day 28
Secondary outcomes (13)
Number of participants with adverse events (AEs)
Measured: From baseline up to 1 year
Median time to neutrophil and platelet count recovery
Median time to neutrophil and platelet count recovery post chemotherapy
Measured: From Day -6 up to 1 year
Rate of HSCT
Percentage of participants going onto hematopoietic stem cell transplantation (HSCT) following SAR445419 treatment but prior to subsequent therapy for treatment of AML
Measured: From baseline up to 1 year
Number of participants with infection
Measured: From baseline up to 1 year
Number of participants by type of infection
Fungal, bacterial, viral, and particularly cytomegalovirus (CMV) infection or reactivation (opportunistic) infection
Measured: From baseline up to 1 year
Percentage of participants with Composite Complete Remission (CRc) rate
Percentage of participants who have a complete remission (CR) or a complete remission with incomplete hematological recovery (CRi) as defined by the modified European LeukemiaNet (ELN) 2022 criteria for AML
Measured: From baseline up to Day 56
Percentage of participants with alternative complete remission rate
Percentage of participants with CR or a complete remission with partial hematological recovery (CRh)
Measured: From baseline up to Day 56
Percentage of participants with overall complete remission rate
Percentage of participants with CR or CRh or CRi or morphological leukemia-free state (MLFS)
Measured: From baseline up to Day 56
Duration of response
Time interval from first documented evidence of CR until progressive disease (PD) as per modified ELN 2022 criteria for AML or death due to any cause, whichever comes first
Measured: From baseline up to 1 year
Duration of event-free survival
Time interval from date of first SAR445419 administration to induction failure, relapse or death due to any cause, whichever comes first
Measured: From baseline up to 1 year
Overall survival rate at 6 months
Time from the first SAR445419 administration to death from any cause
Measured: From baseline up to 6 months
Overall survival rate at 1 year
Time from the first SAR445419 administration to death from any cause
Measured: From baseline up to 1 year
Time to treatment failure
Time from first SAR445419 administration to discontinuation for any reason excluding remission
Measured: From baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start16 Jun 2023
- Primary completion23 Feb 2024
- Study completion12 Mar 2024
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukaemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712278
- Sponsor's protocol ID
- TED17749
- Other IDs
- U1111-1279-2948
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Konopleva M, Bhatt VR, Mantzaris I, Maiti A, Gundabolu K, Schafer J, Jensen K, Saleem R, Li Y, Drewniak A, Bay P, Huh W, Yildirim O, Abbadessa G, Cooley S, Daver N. A phase I, single-arm, open-label, dose-escalation, multicenter study of SAR445419, an off-the-shelf, ex vivo expanded allogeneic natural killer cell product, in participants with relapsed or refractory acute myeloid leukemia. Cancer Immunol Immunother. 2026 Apr 11;75(5):143. doi: 10.1007/s00262-026-04333-y.
PubMed 41963545