Status:
TERMINATED
A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies
Lead Sponsor:
Sanofi
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is 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 treatme...
Detailed Description
Substudy 01: Title: A Phase 1/Phase 2, open-label, multi-center study, assessing the safety, tolerability and the preliminary efficacy of SAR443579 administered in combination with azacitidine + vene...
Eligibility Criteria
Inclusion
- \- 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 is 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:
- Eastern Cooperative Oncology Group (ECOG) performance status 2-3.
- 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.
- Diffusing capacity of the lungs for carbon monoxide (DLCO) ≤65% or forced expiratory volume (FEV1) ≤65%.
- Creatinine clearance ≥30 to \<45 mL/min calculated by modification of diet in renal disease (MDRD) formula.
- Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0x upper limit of normal (ULN).
- Subject 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)
- Subject with adequate liver function demonstrated by the following:
- 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.
- 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
- Any clinically significant, uncontrolled medical conditions (including any serious active systemic infection that is 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:
- HBV as determined by positive test for hepatitis B surface antigen (HBsAg) and/or HBV DNA. Participant who tests positive for anti-hepatitis B core (HBc) antigen IgG (with or without testing positive for anti-HBs), but tests negative for HBsAg and HBV DNA, is eligible.
- A participant who tests positive for anti-HCV antibodies and has undetectable HCV RNA without receiving antiviral treatment for HCV is eligible.
- Active, known, or suspected clinically significant autoimmune disease that has 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 are substrates of CYP enzymes and that cannot 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.
- Subject has received treatment with at least one of the following:
- 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.
- Experimental therapies for AML.
- Concomitant medications of strong and moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06508489
Start Date
August 13 2024
End Date
August 8 2025
Last Update
August 22 2025
Active Locations (7)
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1
City of Hope National Medical Center- Site Number : 8400003
Duarte, California, United States, 91010
2
Montefiore Medical Center - Moses Campus- Site Number : 8400004
The Bronx, New York, United States, 10467
3
The Ohio State University Wexner Medical Center - Ohio State Outpatient Care Upper Arlington- Site Number : 8400001
Columbus, Ohio, United States, 43221
4
Oregon Health and Science University- Site Number : 8400006
Portland, Oregon, United States, 97239