OncoMatch/Clinical Trials/NCT06642025
EX02 CAR-T Cells for Relapsed and Refractory Acute Myeloid Leukemia
Is NCT06642025 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CAR-T Cell for acute myeloid leukemia (aml).
Treatment: CAR-T Cell — This is a early Phase 1 open-label, single-arm clinical study of EX02 CAR-T therapy for relapsed and refractory acute myeloid leukemia. Each participant will undergo leukapheresis after enrolment, receive treatment of the conditioning chemotherapy of cyclophosphamide and fludarabine, and an an intravenous infusion of CAR-T cells. Each participant will proceed through the following study procedures: * Screening * Enrollment/Leukapheresis * Conditioning chemotherapy * CAR T treatment * Post-treatment assessment * Long-term follow-up
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: EX02 positive surface expression
leukemia cells with positive surface expression of EX02
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
hemoglobin > 60g/L, normal T lymphocyte count (CD3+) > 0.5×10^9/L, platelet count > 30×10^9/L
Kidney function
serum creatinine < 178 μmol/L (decompensated phase)
Liver function
AST and ALT ≤ 3x ULN, bilirubin ≤ 3x ULN
Cardiac function
NYHA class I-II only; no myocardial infarction or coronary artery bypass surgery within 6 months; no clinically significant ventricular arrhythmia or unexplained syncope; no severe non-ischemic cardiomyopathy; left ventricular ejection fraction ≥45% within 8 weeks before enrollment
hemoglobin > 60g/L, normal T lymphocyte count (CD3+) > 0.5×10^9/L, platelet count > 30×10^9/L; AST and ALT ≤ 3x ULN, bilirubin ≤ 3x ULN; serum creatinine < 178 μmol/L (decompensated phase); NYHA class III or IV heart failure [excluded]; myocardial infarction or coronary artery bypass surgery within 6 months [excluded]; clinically significant ventricular arrhythmia or unexplained syncope [excluded]; severe non-ischemic cardiomyopathy [excluded]; left ventricular ejection fraction <45% within 8 weeks before enrollment [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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