OncoMatch/Clinical Trials/NCT05748197
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
Is NCT05748197 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT05748197 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic HSCT, clofarabine, cladribine disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages