CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study

Inclusion Criteria: According to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects withrefractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effectivetreatment, met one of the following criteria:

1. relapse: Primordial cells (>5%)in peripheral blood or bone marrow appeared again aftercomplete remission with standard treatment or Extramedullary disease appears，include：
2. Early recurrence within 12 months，
3. Late recurrence at 12 months or above and with no remission after a course ofstandard induction chemotherapy，
4. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;
5. Refractory: patients who have received at least two courses standard induction regimenand failed to achieve a complete response or complete remission was not achieved afterfirst-line or above salvage treatment;
6. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullarylesions were diagnosed as CD7+ by pathological immunohistochemistry at the time ofenrollment and screening;
7. If tumor cells were detected in peripheral blood during enrollment and screening, itwas required to meet the requirement that the surface immunophenotype of tumor cellswas CD4 and CD8 double negative by flow cytometry.
8. Life expectancy greater than 12 weeks;
9. ECOG 0-2;
10. Age 18-75 (upper and lower limits included);
11. HGB at least 70g/L,PLT 50x109/L, can be transfused;
12. Liver and kidney functions The cardiopulmonary functions meet the followingrequirements:
13. Oxygen saturation under air ≥ 92%;
14. LVEF≥50%;
15. Total bilirubin <3×ULN;
16. ALT/AST<3×ULN;
17. Creatinine <1.5×ULN or creatinine clearance rate(Cockroft-Gault)>50ml/min;
18. Informed consent explained to, understood by and signed by patient/ guardian.

Exclusion Criteria: Those who meet any of the following criteria are not eligible to join the group:

1. New York Heart Association (NYHA) classification ≥ grade III heart failure ormyocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris orother clinically prominent heart disease within one year before signing the informedconsent form, Or QTc interval >480ms at screening (QTc interval calculated byFridericia formula);
2. If the patient has a history of hematopoietic stem cell transplantation, 6 monthsafter the patient received allogeneic hematopoietic stem cell transplantation;
3. Those with active GvHD or those who require immunosuppressive therapy;
4. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 yearsprior to screening, except for adequately treated carcinoma in situ of the cervix,basal or squamous cell skin cancer, localized prostate cancer after radical surgery,radical surgery ductal carcinoma in situ;
5. History of non-neoplastic central nervous system disease (Seizures, paralysis,aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)
6. Active or uncontrollable infection requiring systemic treatment within 7 days prior toscreening (except for mild urogenital infections and upper respiratory tractinfections);
7. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus,Crohn's disease) requiring systemic immunosuppressive/systemic disease modulatingmedication within the past 2 years;
8. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B coreantibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA ishigher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need tobe excluded; those with positive human immunodeficiency virus (HIV) antibody; thosewith positive cytomegalovirus (CMV) DNA test; those with positive test for Treponemapallidum specific antibody (TPPA) need to be excluded;
9. Participate in other clinical trials within 4 weeks before the informed consent issigned, or the date of the informed consent is signed and the last medication of thedrug is still within 5 half-lives of the drug (whichever is longer);
10. History of severe allergy to biological products;
11. Unstable systemic disease as judged by the investigator: including but not limited tosevere liver, kidney or metabolic disease requiring drug therapy;
12. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 yearsof cell infusion or male subjects whose partner is planning pregnancy within 2 yearsof cell infusion;
13. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior toscreening;
14. Circumstances that the investigator believes may increase the risk to the subject orinterfere with the results of the trial.