First-in-human Study of SAR443579 Infusion in Male and Female Participants of at Least 12 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL) or High Risk-myelodysplasia (HR-MDS)

  • End date
    Apr 20, 2026
  • participants needed
  • sponsor
Updated on 7 October 2022


This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.


2.5 years.

Condition Acute Lymphocytic Leukaemia; Acute Myeloid Leukaemia Refractory; Myelodysplastic Syndrome
Treatment SAR443579
Clinical Study IdentifierNCT05086315
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Participant must be ≥12 years old at the time the trial participant or legal guardian signs the informed consent form
For participants of the Escalation Part only
Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification. Patients with AML must meet one of the following criteria, a), b) or c) and are limited to those with no available (or are ineligible) therapy with known clinical benefit
Primary Induction Failure (PIF) AML, defined as disease refractory to one of the following, i or ii
An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens
Examples include but are not limited to
One cycle of high dose cytarabine (HiDAC) containing regimen
One cycle of liposomal cytarabine and daunorubicin
Two cycles of standard dose cytarabine containing regimen ii) For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens, 1 or 2
4 cycles of hypomethylating agents (HMA) or
2 cycles HMA + venetoclax b) Early relapse (ER) AML, defined as AML in relapse with CR duration < 6 months from most recent treatment c) Leukemia in first or higher relapse
Confirmed diagnosis of cluster of differentiation 123 (CD123) + HR-MDS, with a Revised International Prognostic Scoring System (IPSS-R) risk category of intermediate or higher and are limited to those with no available (or are ineligible) therapy with known clinical benefit
Not eligible for induction therapy and having completed ≥2 cycles of any of the
following: hypomethylating agent (eg, 5 azacitidine or decitabine) and/or
venetoclax, chemotherapy, or targeted agents
Not eligible for autologous stem cell transplant (ASCT) and having completed ≥1 course of induction therapy
Confirmed diagnosis of CD123 + B-ALL without extramedullary lesions that have no available (or are ineligible) therapy with known clinical benefit
For Participants in the Expansion Part Only
For participants in Cohort A: Participants meeting inclusion criteria for AML patients that have been primary refractory (PIF) to prior induction treatment or who have had ER occurring 6 months or less after an initial remission on prior induction treatment
For participants in Cohort B: Participants meeting inclusion criteria for AML patients that have had late relapse (LR), occurring more than 6 months after an initial remission on prior induction treatment
Body weight >40 kg. -- Body weight >40 kg. - - -

Exclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status >2 (≥18 years-old). Karnovsky Scale (16-17 years-old) <50% or Lansky Scale (<16 years-old) <50%
History of an active or chronic autoimmune condition that has required or requires therapy
Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed
Evidence of active central nervous system leukemia at the time of enrollment as evidenced by cytology or pathology
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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants with a history of SARS-CoV-2 infection must have completed clinical recovery at least 1 month prior to enrollment. - Prior treatment with an anti-CD123-directed agent
Prior HSCT with relapse beyond 3 months may be included only if off immunosuppression for a minimum of 4 weeks and no evidence of graft versus host disease (GVHD)
Receiving at the time of first investigational medicinal product (IMP) administration corticosteroid as a concomitant medication with corticosteroid dose >10 mg/day of oral prednisone or the equivalent
Prior treatment with cellular therapy, eg, chimeric antigen receptor T cell (CAR-T) or chimeric antigen receptor NK cell (CAR-NK)
Concurrent treatment with other investigational drugs
Radiotherapy, even if palliative in intent, may not be given during the study
Prophylactic use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin) during the DLT observation period in the Dose Escalation Part only. - Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
Pregnant and breast-feeding women
History of solid organ transplant, including corneal transplant
Average QTc (using the Fridericia correction calculation) >470 millisecond (msec) at screening
The above information is not intended to contain all considerations relevant to a potential
participation in a clinical trial
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