OncoMatch/Clinical Trials/NCT07036250
Clinical Study of U32 in Patients With Acute Myeloid Leukemia
Is NCT07036250 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies U32 CAR-T for acute myeloid leukaemia.
Treatment: U32 CAR-T — This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD38 positive expression
Positive expression of CD38 or CLL-1 confirmed by immunohistochemistry or flow cytometry
Required: CLEC12A positive expression
Positive expression of CD38 or CLL-1 confirmed by immunohistochemistry or flow cytometry
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Lab requirements
Blood counts
ALC ≥0.3×10^9/L, platelets ≥20×10^9/L (including with platelet transfusion support), hemoglobin ≥60 g/L or maintained at this level after transfusion
Kidney function
serum creatinine ≤1.5x ULN, or creatinine clearance rate ≥60 mL/min
Liver function
AST ≤3x ULN; ALT ≤3x ULN; total bilirubin ≤1.5x ULN
Cardiac function
peripheral capillary oxygen saturation ≥92%; LVEF ≥45%
Have adequate bone marrow reserve at screening, defined as: absolute lymphocyte count (ALC) ≥0.3×10^9/L, platelets (PLT) ≥20×10^9/L (including with platelet transfusion support). Have appropriate organ function: aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; hemoglobin ≥60 g/L or maintained at this level after transfusion; peripheral capillary oxygen saturation ≥92%; left ventricular ejection fraction (LVEF) ≥45%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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