Clinical Study of CLL-1 CAR-T in the Treatment of Children With R/R AML

Exclusion Criteria

• •1. Diagnosis of APL.
• •2. History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery.
• •3. Evidence of CNS involvement or cranial nerve pathology.
• •4. Subjects with active infections such as hepatitis B, hepatitis C, etc., are to be excluded.
• •5. Subjects with a history of severe allergies or known allergy to any drug component included in this study are to be excluded.
• •6. Subjects with severe cardiac diseases, refractory hypertension, active neurological autoimmune or inflammatory diseases, clinically significant active cerebrovascular disease, oncologic emergencies requiring urgent intervention, acute or chronic GVHD, or any uncontrolled infections requiring antibiotic therapy, etc., are unsuitable for enrollment.
• •7. Previous organ transplant or planned organ transplant (except for hematopoietic stem cell transplantation).
• •8. Received allo-HSCT within 6 weeks prior to screening.
• •9. Subjects who have recently undergone major surgery or plan to undergo major surgery, excluding diagnostic procedures and biopsies.
• •10. Subjects with severe mental disorders, alcoholism, or drug abuse.
• •11. Subjects who, in the judgment of the investigator, have other conditions that make them unsuitable for enrollment.