A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma

Exclusion Criteria

• •1. When collecting and preparing CAR-T blood, those with a tumor load greater than 70%;
• •2. Have malignant tumors other than T-cell hematological malignancies within 5 years, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, breast ductal carcinoma in situ after radical resection cancer.
• •3. CNS leukemia patients with clinical symptoms.
• •4. Hepatitis B surface antigen (HBsAg) is positive, hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Positive individuals for cytomegalovirus (CMV) DNA testing; Syphilis test positive.
• •5. Those with a history of severe allergies or known any of the active ingredients, excipients or mouse-derived products contained in the drug, or those allergic to xenogeneic proteins in this trial, including lymphocyte depletion regimens. Severe allergy history is defined as an allergic reaction of grade two or above, and any of the following clinical manifestations occur when an allergic reaction occurs: airway obstruction (runny nose, cough, wheezing, dyspnea), hypercardia tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiration, cardiac arrest.
• •6. Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory Hypertension is defined as: on the basis of improving lifestyle, a reasonable tolerable and sufficient amount of ≥3 kinds of antihypertensive drugs (including diuretics) has been used for \> 1 month and the blood pressure has not reached the standard, or the blood pressure can only be achieved effective control after taking ≥4 kinds of antihypertensive drugs.
• •7. Have unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy.
• •8. Those who have received organ transplants or are about to receive organ transplants (except for hematopoietic stem cell transplants).
• •9. Patients with acute and chronic graft-versus-host disease (GVHD).
• •10. Patients who received hematopoietic stem cell transplantation within 6 months before screening and who have active GVHD after stopping Immunosuppressive drug therapy.
• •11. Active autoimmune or inflammatory diseases of the nervous system (eg, Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular disease (eg, cerebral edema) , Posterior Reversible Encephalopathy Syndrome (PRES)).
• •12. Those who have tumor emergencies (such as spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome, etc.) before screening or reinfusion and need emergency treatment.
• •13. The presence of an uncontrolled bacterial, fungal, viral or other infection requiring antibiotic treatment.
• •14. Those who have undergone major surgical operations (except diagnostic surgery and biopsy) within 4 weeks before clearing the lymph cells, or those who plan to undergo major surgery during the study period, or those whose surgical wounds have not healed completely before enrollment.
• •15. Those who have received (attenuated) live virus vaccine within 4 weeks before screening.
• •16. Persons with severe mental illness.
• •17. Those who are alcoholics or have a history of drug abuse.
• •18. Pregnant or lactating women, female subjects who plan to become pregnant within 2 years after cell reinfusion, and male subjects whose partners plan to become pregnant within 2 years after cell reinfusion.
• •19. Patients with contraindications to any research procedure or with other medical conditions that may expose them to unacceptable risks at the discretion of the investigator and/or clinical criteria.