To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT

Exclusion Criteria

• •Subjects with any of the following conditions will not be eligible for inclusion in this study.
• •1. A history of CNS diseases, including but not limited to epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and neuropathy. A history of diseases without related neurological symptoms before screening, such as lacunar infarction, etc., will be excluded at the discretion of the investigator.
• •2. Any uncontrolled active infection within 4 weeks before signing the ICF or before apheresis.
• •3. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at screening and peripheral blood hepatitis B virus (HBV) DNA above the detection limit, positive hepatitis C virus (HCV) antibody and positive HCV RNA, positive human immunodeficiency virus (HIV) antibody, cytomegalovirus (CMV) DNA above the detection limit, Epstein-Barr virus (EBV) DNA above the detection limit, and both specific and non-specific antibodies for Treponema pallidum positive need to be excluded.
• •4. Clinically significant cardiovascular diseases, including any of the following:
• •1. Corrected QTc interval ≥ 480 ms (QTc interval calculated by the Fridericia formula);
• •2. New York Heart Association (NYHA) class II or higher heart failure;
• •3. Unstable angina or acute myocardial infarction within 6 months before signing the ICF;
• •4. Left ventricular ejection fraction (LVEF) \< 50%;
• •5. Uncontrolled hypertension (judged by the investigator based on the individual condition of the subject);
• •6. Clinically significant or requiring antiarrhythmic treatment arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, and complete left bundle branch block, etc.).
• •5. Allergy to any component of the drugs to be used in this study.
• •6. Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression.
• •7. Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period.
• •8. Received systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations:
• •1. Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections);
• •2. Systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose;
• •3. Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography \[CT\]);
• •4. For the treatment of adverse reactions after reinfusion.
• •9. Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period.
• •10. Had active tuberculosis infection within 1 year before signing the ICF (except for subjects with active tuberculosis infection more than 1 year ago and judged by the investigator to have no evidence of active tuberculosis at present).
• •11. Received live attenuated vaccines within 4 weeks before signing the ICF or planned to receive live attenuated vaccines during the screening period.
• •12. The investigator believes that the subject's complications or other conditions may affect compliance with the protocol or are not suitable for participation in this study.
• •13. Pregnant or lactating.