A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies

This was a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or adult participants with CD123 expressing hematological malignancies. This protocol was structured as a master protocol (containing common protocol elements). Individual sub-studies would explore SAR443579 with combination partners, which might include approved or investigational agents. Experimental sub-studies would be tested through 3 parts: Part 1: dose finding (such as dose escalation/ safety run-in). Part 2: dose optimization (when applicable). Part 3: dose expansion. In each sub-study, a dose escalation would identify preliminary recommended dose for expansion (pRDE) of SAR443579 and its respective combination partner. Following the determination of the preliminary RDE, additional participants would be enrolled in the dose expansion part, or if dose optimization needs to be further evaluated, additional participants would be enrolled in the "dose optimization/expansion" part. Dose optimization and dose expansion part could involve randomization depending on specific sub-study design. Study consisted of a screening period, treatment period, and follow-up period. Participants would receive study treatment until documented disease progression, unacceptable adverse events, participant's decision to stop study treatment, or completion of the maximum cycles allowed in the sub-studies, or the participant met other criteria for discontinuation per study protocol (whichever occurred first).

Inclusion Criteria: \- Participants with CD123-expressing hematological neoplasm per the 5th edition of the WHO Classification of Hematolymphoid Tumors. Substudy 01: * Participants must be ≥18 years of age * Confirmed diagnosis of Acute Myeloid Leukemia * Ineligible for intensive chemotherapy. Ineligible for intensive chemotherapy was defined by the following criteria: A) ≥ 75 years of age, OR B) 18 to 74 years of age and meeting one or more of the following: 1. Eastern Cooperative Oncology Group (ECOG) performance status 2-3. 2. Cardiac history of congestive heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% or symptomatic coronary heart disease confirmed by coronarography or cardiac imaging. 3. Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume (FEV1) ≤65%. 4. Creatinine clearance ≥30 to \1.5 to ≤3.0x upper limit of normal (ULN). * Participant with an Eastern Cooperative Oncology Group (ECOG) performance status as follows: a) 0 to 2 for participants ≥75 years of age or b) 0 to 3 for participants 18 to 74 years of age. * For participants ≥75 years of age, adequate renal function demonstrated by a creatinine clearance ≥30 mL/min, calculated by modification of diet in renal disease (MDRD) * Participant with adequate liver function demonstrated by the following: 1. For participants 18 to 74 years of age, aspartate aminotransferase (AST) ≤3.0 × ULN, alanine aminotransferase (ALT) ≤3.0 × ULN and bilirubin ≤3.0 × ULN, unless considered due to leukemic organ involvement ˂5 × ULN. 2. For participants ≥75 years of age, aspartate aminotransferase (AST) ≤3.0 × ULN, alanine aminotransferase (ALT) ≤3.0 × ULN and bilirubin ≤1.5 × ULN, unless considered due to leukemic organ involvement ˂5 × ULN. Exclusion Criteria: * Any clinically significant, uncontrolled medical conditions (including any serious active systemic infection that was not controlled) * Known second malignancy either progressing or requiring active treatment within the last 3 years prior to first IMP administration * Known acquired immunodeficiency syndrome (AIDS-related illnesses) or HIV disease requiring antiretroviral treatment, or having active hepatitis B or C infection, or SARS-CoV-2 infection. With exception for: 1. HBV as determined by positive test for hepatitis B surface antigen (HBsAg) and/or HBV DNA. Participant who tested positive for anti-hepatitis B core (HBc) antigen IgG (with or without testing positive for anti-HBs), but tested negative for HBsAg and HBV DNA, was eligible. 2. A participant who tested positive for anti-HCV antibodies and had undetectable HCV RNA without receiving antiviral treatment for HCV was eligible. * Active, known, or suspected clinically significant autoimmune disease that had required systemic treatment in the past 2 years prior to first IMP administration, except controlled by replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) * Predicted life expectancy ≤3 months. * Medical conditions requiring treatment with medications with narrow therapeutic index that were substrates of CYP enzymes and that could not be closely monitored to allow for dose adjustment. * Ongoing adverse event of NCI CTCAE \[Version 5.0\] Grade 2 or greater severity cause by any prior anti-cancer therapy Substudy 01: * Patient with Acute Promyelocytic Leukemia (APL) * Known active central nervous system involvement with AML at the time of enrollment as evidenced by cytology or pathology * Cardiovascular disease of New York Heart Association (NYHA) Class ≥2. * Malabsorption syndrome or other condition that precludes enteral route of administration * A baseline QTc interval of (using the Fridericia correction calculation) \>470 msec. * Participant had received treatment with at least one of the following: 1. A hypomethylating agent, venetoclax and/or chemo therapeutic agent for AML other than hydroxyurea used for disease control prior to the initiation of study therapy. 2. Experimental therapies for AML. 3. Concomitant medications of strong and moderate CYP3A inducers within 7 days prior to the initiation of study treatment. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.