A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia

Eligibility Criteria

• 1. Age ≥18 years of age at the time of signing informed consent.
• 2. Patients must have R/R AML. The following disease status will be eligible for the study:
• 3. ECOG performance status 0 or 1.
• 4. Subjects must have a suitable stem cell donor identified who may donate cells in the event that the subject needs to undergo an allogeneic HSCT for rescue from prolonged marrow aplasia.
• 5. Adequate organ function defined as:
• 1. Serum creatinine \<2.0 mg/100 mL.
• 2. Total bilirubin \<2.0 mg/100 mL, unless benign congenital hyperbilirubinemia or due to leukemia organ involvement
• 3. AST and/or ALT ≤5 × ULN, unless considered due to leukemic organ involvement.
• 1. Diagnosis of acute promyelocytic leukemia.
• 2. Radiologically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5/µL WBCs in CSF). Subjects with adequately treated CNS leukemia are eligible.
• 3. Oxygen saturation \<90% on room air.
• 4. Patients with prior allogeneic HSCT are allowed as long as HSCT occurred \> 3 months of signing ICF and without ongoing requirement for systemic graft-versus-host therapy.
• 5. Treatment with clofarabine or cladribine within 3 months prior to leukapheresis
• 6. The following medications are excluded:
• 1. Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
• 2. Chemotherapy: Should be stopped one week prior to leukapheresis or starting conditioning chemotherapy. Hydroxyurea for cytoreduction can be administered up to 72 hours before leukapheresis or CAR T cell infusion.
• 7. Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher; or cardiac ejection fraction \<40%.
• 8. Uncontrolled clinically significant infections such as ongoing fever for 48 hours, persistent bacteremia or requiring new supplemental oxygen.
• 9. Previous treatment with CAR therapy
• 10. Positive serologic test results for HIV.
• 11. Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+. 12. Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR.
• 13. Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \>2 years before screening.
• 14. Live vaccine within 4 weeks prior to leukapheresis 15. Pregnant or lactating/breastfeeding women 16. Any prior or ongoing condition/issue that in the opinion of the investigator would make the patient ineligible for study