Tests universal CAR-T cells in people with relapsed or hard-to-treat acute myeloid leukemia
Tests engineered immune cells against leukemia in people with relapsed disease.
Plain-language title generated from the registry record
Registry title: Universal CAR-T Cells Targeting AML
Key facts
- Where
- Shenzhen, ChinaSee the site
- Phase
- Phase 1
Where in China
- Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Geno-Immune Medical Institute
- Trial code
- NCT05995041
- Record updated
- 2 November 2026
- Original description
The 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.Read full original descriptionShow less
Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia
The 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.
Inclusion: Age older than 6 months; Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry; Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 months; 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; No cell separation contraindications; Abilities to understand and the willingness to provide written informed consent.
Exclusion: Use of glucocorticoid for systemic therapy within one week prior to entering the trial; Previous treatment with any gene therapy products; Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection; Active bacterial, fungal or viral infection not controlled by adequate treatment; Known HIV or active hepatitis C virus (HCV) infection; Pregnant or nursing women may not participate; The bone marrow AML burden (MRD) is above 50%; Patients, in the opinion of investigators, may not be able to comply with the study.