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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.

Phase 1/2RecruitingShanghai Unicar-Therapy Bio-medicine Technology Co.,LtdNCT07036250Data as of May 2026

Treatment: U32 CAR-TThis is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.

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Extracted 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

Min 2 prior lines

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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