Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

The CARs consist of an anti-CD7 single-chain variable fragment（scFv）, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Inclusion criteria

• Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；
• CD7 expression in tumor cells was detected by flow cytometry；
• Life expectancy greater than 12 weeks；
• KPS or Lansky score≥60;
• HGB≥70g/L (can be transfused);
• 2-70 years old;
• Oxygen saturation of blood#90%#;
• HGB≥70g/L（blood transfusion allowed）;
• Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
• Informed consent explained to, understood by and signed by patient/ guardian.

Exclusion criteria

• Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
• Has an active GvHD;
• Has a history of severe pulmonary function damaging;
• With other tumors which is/are in advanced malignant and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled;
• Merging severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
• Patients with HIV infection or syphilis infection;
• Has a history of serious allergies on Biological products (including antibiotics);
• Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6;
• Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
• Have received transplant treatment for less than 6 months in prior to enrollment;
• Being pregnant and lactating or having pregnancy within 12 months;
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.