Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells: Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
Study 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
Sex
ALL
Min age
2 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age older than 2 years.
2. CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 2 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 hepatitis B virus (HBV) infection.
4. Pregnant or nursing women may not participate.
5. History of glucocorticoid for systemic therapy within the week prior to entering the test.
6. Previously treatment with any gene therapy products.
7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Primary outcome measure(s)
percentage of patients with treatment related adverse effect — a year percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical labs and so on.
Trial sites (1)
Facility
City
Region
Status
Shenzhen Geno-immune Medical Institute
Shenzhen
Guangdong
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.
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