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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with acute myeloid leukemia (AML) that came back or did not respond to treatment, whose leukemia cells carry CLL-1, CD123, CD38 and/or CD33.
- Age
- Older than 6 months, up to 75 Years
- Sex
- All sexes
- Disease stage
- Relapsed or refractory acute myeloid leukemia (AML). Bone marrow AML burden (MRD) must not be above 50%.
- Earlier treatment
- Cannot have had any gene therapy product. Cannot have used glucocorticoids for whole-body therapy within one week before the trial.
- Biomarker or test result
- Leukemia cells must show CLL-1, CD123, CD38 and/or CD33, confirmed by immuno-histochemical staining or flow cytometry.
Main reasons for not taking part
- Active infection not controlled by treatment
- Known HIV or active hepatitis C virus (HCV) infection
- Pregnant or nursing women
- Previous gene therapy
- Severe illness that would not allow following the trial plan
Read by machine on 9 November 2026.
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.