OncoMatch/Clinical Trials/NCT05748197
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
Is NCT05748197 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including ADCLEC.syn1 CAR T cells and Conditioning chemotherapy for acute myeloid leukemia.
Treatment: ADCLEC.syn1 CAR T cells · Conditioning chemotherapy — The purpose of this study is to test the safety of ADCLEC.syn1 CAR T cells in people with relapsed or refractory AML. The researchers will try to find the highest dose of ADCLEC.syn1 CAR T cells that causes few or mild side effects in participants. Once the researchers find this dose, it will test it in a new group of participants to see if it is effective in treating their relapsed/refractory AML.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: intensive induction chemotherapy (7+3, MEC, HiDAC) — induction
failure to achieve a CR, CRh or CRi after at least one course of standard intensive induction chemotherapy (e.g., 7+3, MEC, HiDAC, etc.)
Must have received: hypomethylating agent — induction
failure to achieve a CR, CRh or CRi after hypomethylating agent (HMA) or low dose cytarabine-based combination regimen including but not limited to venetoclax (e.g. venetoclax in combination with azacytidine, decitabine or cytarabine)
Must have received: hypomethylating agent — induction
Four cycles of HMA monotherapy
Cannot have received: allogeneic HSCT
Exception: allowed if HSCT occurred > 3 months before signing ICF and without ongoing requirement for systemic graft-versus-host therapy
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.
Cannot have received: clofarabine (clofarabine)
Treatment with clofarabine ... within 3 months prior to leukapheresis
Cannot have received: cladribine (cladribine)
Treatment with ... cladribine within 3 months prior to leukapheresis
Lab requirements
Kidney function
Serum creatinine <2.0 mg/100 mL.
Liver function
Total bilirubin <2.0 mg/100 mL, unless benign congenital hyperbilirubinemia or due to leukemia organ involvement; AST and/or ALT ≤5 × ULN, unless considered due to leukemic organ involvement.
Adequate organ function defined as: Serum creatinine <2.0 mg/100 mL. Total bilirubin <2.0 mg/100 mL, unless benign congenital hyperbilirubinemia or due to leukemia organ involvement. AST and/or ALT ≤5 × ULN, unless considered due to leukemic organ involvement.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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