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Clinical Trials in China / NCT05995041
Starting soon Phase 1

Universal CAR-T Cells Targeting AML

NCT05995041 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Geno-Immune Medical Institute
Phase
Phase 1
Started
2027-06-30
Last updated
2026-08-27

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells

CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells: Infusion of CLL-1, CD33, CD38 and/or CD123-specific universal CAR- T cells

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Months
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age older than 6 months. 2. Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. 4. 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. 5. Hgb≥80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or active hepatitis C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. Previous treatment with any gene therapy products. 7. The bone marrow AML burden (MRD) is above 50%. 8. Patients, in the opinion of investigators, may not be able to comply with the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Geno-Immune Medical Institute Shenzhen Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05995041 on ClinicalTrials.gov ↗ ← All trials in China