Clinical Study of the Safety and Efficacy of ASCT Combined With CD7-CART in the Treatment of CD7+ TCL

Inclusion Criteria

• •1. With the subject's consent and having signed the informed consent form, willing and capable of adhering to the planned visits, study treatment, laboratory tests and other trial procedures;
• •2. Age 18 to 65 years old, both male and female;
• •3. Confirmed as T-cell non-Hodgkin's lymphoma type (including T-lymphoblastic lymphoma/leukemia) according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022), and meeting one of the following three conditions: 1) Newly diagnosed with high-risk factors, such as Ann Arbor stage III/IV, large mass, bone marrow invasion, central nervous system (CNS) invasion, ETP phenotype, RAS activating mutation, TP53 deletion/mutation, etc., as assessed by the investigator; 2) Not achieving PR or better response after induction and consolidation therapy; 3) Patients not considered for allogeneic hematopoietic stem cell transplantation;
• •4. Confirmed as tumor cells expressing CD7 by histopathology and/or cytology at the time of screening;
• •5. With appropriate organ function: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN), if the investigator determines that the abnormal ALT and AST are due to the disease (such as liver infiltration or bile duct obstruction), the indicators can be relaxed to ≤ 5 times ULN; 2) Total serum bilirubin ≤ 2 times ULN, except for patients with Gilbert's syndrome; patients with Gilbert's syndrome and total bilirubin ≤ 3 times ULN and direct bilirubin ≤ 1.5 times ULN can be included; 3) Serum creatinine clearance rate ≥ 30 mL/min; 4) International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN; 5) Possessing the minimum level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and non-oxygen-dependent blood oxygen saturation ≥ 92%; 6) Left ventricular ejection fraction ≥ 50% by echocardiography; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion and pleural effusion.
• •6. Women of childbearing age have a negative blood/urine pregnancy test within 7 days before infusion. Any male and female patients with fertility must agree to use effective contraceptive methods throughout the study and for at least 2 years after the administration of study treatment.
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