Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia
Shenzhen Geno-Immune Medical Institute
10 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.
Eligibility
Inclusion Criteria7
- Age older than 2 years.
- CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
- Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 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 Criteria7
- 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 hepatitis B virus (HBV) infection.
- Pregnant or nursing women may not participate.
- History of glucocorticoid for systemic therapy within the week prior to entering the test.
- Previously treatment with any gene therapy products.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
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Interventions
Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03222674