CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study

This is an interventional treatment trial for T Lymphoblastic Leukemia/Lymphoma Read More

Inclusion Criteria:

• The age ranged from 7 to 70 years (including the cut-off value), regardless of gender
• The expected survival time was more than 6 weeks
• ECOG score 0-1
• Malignant lymphoma (including but not limited to acute T-lymphoblastic leukemia / lymphoma; extramedullary NK / T-cell lymphoma, nasal type; peripheral T-cell lymphoma, nonspecific; vascular immunoblastic T-cell lymphoma; intestinal disease associated T-cell lymphomas; anaplastic large cell lymphoma (ALK -); T-cell lymphoblastic leukemia)

• When screening, hematological malignancies with CD7 Positive confirmed by bone marrow examination or tumor pathology with positive rate of CD7 ≥ 30%, meeting one of the following conditions:

  1. At least two chemotherapy regimens failed or did not achieve complete remission or relapse;
  2. Patients who relapsed after stem cell transplantation were not affected by other treatment methods;
• For peripheral blood involved acute T-lymphoblastic leukemia / lymphoma and NK / T-cell lymphoma, patients with TCR rearrangement were detected by ngs

• The liver and kidney function, heart and lung function meet the following requirements:

  1. Creatinine ≤ 1.5 ULN;
  2. LVEF ≥ 45%;
  3. Blood oxygen saturation > 91%;
  4. The total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; the abnormal ALT and AST caused by diseases (such as liver infiltration or bile duct obstruction) can be relaxed to ≤ 5 × ULN;
• Understand the experiment and have signed the informed consent

Exclusion Criteria:

• Those who need immunosuppressant;
• For intestinal disease-related T-cell lymphoma, patients with intestinal ulcer or hematochezia were examined by colonoscopy;
• In addition to cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation, and breast ductal carcinoma in situ after radical operation;
• The patients with positive HBsAg or HBcAb and HBV DNA titer in peripheral blood were not within the normal reference value; those with positive anti HCV antibody and positive HCV RNA in peripheral blood; those with HIV antibody positive and cytomegalovirus DNA positive Syphilis was positive;
• Severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), severe arrhythmia;
• Unstable systemic diseases judged by researchers: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
• Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except for mild genitourinary system infection and upper respiratory tract infection);
• Pregnant or lactating women, female subjects planning pregnancy within 1 year after cell reinfusion or male subjects whose partners plan to conceive within 1 year after cell reinfusion;
• Patients who had received car-t therapy or other gene modified cell therapy before screening;
• Subjects who were receiving systemic steroid therapy or were receiving systemic steroid therapy for 7 days were excluded;
• Participated in other clinical studies within 3 months before screening;
• There was evidence of central nervous system invasion during screening;
• According to the judgment of the researchers, it does not conform to the condition of cell preparation;
• Other researchers think it is not suitable to be included in the study.