Universal CAR-T Cells Targeting AML

Korábbi kezelés

• Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
• Previous treatment with any gene therapy products.

Más betegség

• 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.

Egyéb

• 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.

• 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.