Overview

This study is a multicenter, non randomized, single arm, open clinical trial. The selected disease was relapsed / refractory NHL, and the disease was classified into highly aggressive lymphoma, invasive lymphoma and inert lymphoma; Highly invasive NHL included Burkitt lymphoma (BL), lymphoblastic lymphoma (LBL), high-grade B-cell lymphoma, etc; Invasive NHL includes diffuse large B-cell lymphoma, mantle cell lymphoma and peripheral T-cell lymphoma; Inert NHL contains follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

Eligibility

Inclusion Criteria:

        Fully understand and voluntarily sign the informed consent form, and be willing and able to
        comply with the visit, treatment plan, laboratory examination and other requirements of the
        study specified in the test flow sheet; 2. Patients with hematopoiesis and lymphoid tissue
        tumors diagnosed as relapsed and refractory by clinical diagnosis were defined as relapse
        or refractory
          1. Primary drug resistance to standard treatment regimen;
          2. Or PD occurred after at least second-line standard treatment;
          3. Or the last treatment effect was SD and lasted no more than 6 months;
          4. Or CD20 positive patients were ineffective or relapsed after anti-CD20 mAb treatment;
          5. Or PD after autologous hematopoietic stem cell transplantation, or recurrence
             confirmed by biopsy within 12 months, or salvage treatment after autologous
             hematopoietic stem cell transplantation has no remission or recurrence after
             treatment.
             3. According to RECIST version 1.1 , there should be at least one measurable tumor
             focus; 4. Subjects with ECoG score of 0-2 5. 14 years old ≤ age ≤ 75 years old, both
             male and female; 6. The tumor cells were positive for CD19 or CD22 / CD30 / CD7 / CD79
             by immunohistochemistry or flow cytometry; 7. The expected survival time is more than
             3 months from the date of signing the informed consent； 8. Laboratory examinations
             meet the following conditions: hemoglobin ≥80g/L, platelet count ≥50 × 10^9/L,
             absolute neutrophil count (ANC) ≥1.0 × 10^9/L, if the investigator believes that the
             above inspection value is below the lower limit It is caused by tumor invading bone
             marrow and can be included in the group after consultation with the sponsor; 9. The
             main organ function indicators meet the following conditions: AST (aspartate
             aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN,
             serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejection
             fraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higher
             than level 1 and blood oxygen saturation> 92% under indoor conditions).
             Exclusion Criteria:
               1. Severe cardiac insufficiency, left ventricular ejection fraction <50%;
               2. There is a history of severe lung dysfunction diseases;
               3. The patient has had other malignant tumors in the past 5 years, except for skin
                  basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ
                  that have undergone radical treatment;
               4. Combined with severe or persistent infection and cannot be effectively
                  controlled; Severe infection: Refers to sepsis or uncontrolled infection of the
                  infected foci, and can be included in the group after infection is controlled
               5. Combined metabolic diseases (except diabetes);
               6. Combined with severe autoimmune disease or innate immune deficiency;
               7. Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface
                  antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver
                  function; hepatitis C, defined as hepatitis C antibody [ HCV-Ab] positive,
                  HCV-RNA higher than the detection limit of the analysis method and abnormal liver
                  function) or combined with hepatitis B and C co-infection;
               8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency
                  syndrome (AIDS), or syphilis infection;
               9. A history of severe allergies to biological products (including antibiotics);
              10. Participate in any other clinical drug trials at the same time within one month;
              11. There are other serious physical or mental illnesses or laboratory abnormalities
                  that may increase the risk of participating in the research, or interfere with
                  the results of the research, and patients who the researcher believes are not
                  suitable for participating in this research.