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OncoMatch/Clinical Trials/NCT05995041

Universal CAR-T Cells Targeting AML

Is NCT05995041 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells for acute myeloid leukemia.

Phase 1RecruitingShenzhen Geno-Immune Medical InstituteNCT05995041Data as of May 2026

Treatment: CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cellsThe purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: CLEC12A overexpression

Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry

Required: IL3RA overexpression

Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry

Required: CD38 overexpression

Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry

Required: CD33 overexpression

Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry

Prior therapy

Cannot have received: gene therapy

Lab requirements

Blood counts

Hgb≥80g/L

Kidney function

creatinine ≤ 2.5 × upper limit of normal

Liver function

AST and ALT ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL

Cardiac function

cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%

Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. Hgb≥80g/L.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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