CAR-T CD19/CD20 for Patients With Advanced CD19/CD20+ B Cell Line Recurrent or Refractory Hematological Malignancies
CAR-T CD19/CD20 for Patients With Advanced CD19/CD20+ B Cell Line Recurrent or Refractory Hematological Malignancies
This is a clinical study of CD19 / CD20 CAR-T cell infusion in the treatment of relapsed or
 refractory hematological malignancies in CD19 / CD20 positive B cell lines.

 The aim of this study was to evaluate the efficacy and safety of autologous chimeric antigen
 receptor T cell infusion targeting CD19/CD20 in the treatment of relapsed or refractory CD19
 / CD20 positive B cell line hematological malignancies.
CD19 and CD20 are two proteins expressed in normal B cells and various B cell-derived
 hematological malignancies, including non Hodgkin's lymphoma (NHL), acute lymphoblastic
 leukemia (all) and chronic lymphoblastic leukemia (CLL). CD19 and CD20 are restricted to the
 surface of B cells. They are not expressed in hematopoietic stem cells, nor in other tissue
 cells. They exist in all stages of B cell development and differentiation. They are not lost
 from the cell surface until B cells differentiate into plasma cells. Clinical studies have
 found that CD19 and CD20 are excellent targets for immunotherapy of B-cell malignancies.The
 purpose of this study was to observe the efficacy and safety of treatment for patients with
 relapsed or refractory CD19 / CD20 positive B cell line hematological malignancies.
Inclusion Criteria:

 Only subjects meeting all of the following conditions were included in the study:

 -  The subjects who voluntarily participated in the study and signed the written informed
 consent;

 -  The age at the time of signing the informed consent is 3-70 years old, regardless of
 gender or race;

 -  The patients with CD19 / CD20 positive hematological malignancies without other
 effective treatment options include those who are not suitable for allogeneic stem
 cell transplantation (SCT) due to the following reasons:Age; Concurrent diseases;
 Other contraindications, such as total body irradiation (TBI) contraindications (TBI
 is one of the important treatment measures before allogeneic stem cell transplantation
 in all patients); Lack of suitable donors;

 -  Expected survival > 12 weeks;

 -  Relapse after any stem cell transplantation (no matter what previous treatment plan);
 and;

 -  Patients who relapsed after previous allogeneic SCT (myeloablative or non
 myeloablative) and met all other inclusion criteria:

 1. There was no active GVHD and no immunosuppression was required;

 2. Transplantation lasted more than 4 months;

 -  Serum creatinine ≤ 1.6 mg / dl and / or urea nitrogen ≤ 1.5 mg / dl;

 -  Serum AST and alt ≤ 5 x upper limit of normal value (ULN);

 -  It is necessary to have indicators for disease detection or evaluation, including
 detection of minimal residual disease (MRD) by immunophenotyping, cytogenetics or PCR;

 -  Cardiac function: left ventricular ejection fraction greater than or equal to 40%;

 -  ECoG physical condition (PS) ≤ 2;

 -  The pregnant test results of fertile female subjects within 48 hours before the
 infusion were negative and they were not in lactation period; all fertile female
 subjects took adequate contraceptive measures before entering the study and within 3
 months after stopping the last infusion during the whole study period.

 Exclusion criteria:

 -  Pregnant or lactating female patients;

 -  Participate in another clinical trial within 4 weeks before the study, or intend to
 participate in another clinical trial during the whole study period;

 -  Uncontrolled active infection;

 -  The history of human immunodeficiency virus is known;

 -  Active hepatitis B or hepatitis C infection;

 -  The systemic steroid treatment is needed during cell infusion or cell collection, or
 there are some diseases that researchers think may need steroid treatment during blood
 collection or infusion. In addition to cell collection or infusion, steroids for
 disease treatment are allowed, and inhaled steroids or hydrocortisone for
 physiological replacement therapy in patients with adrenocortical insufficiency are
 also allowed;

 -  There are grade 2-4 acute or systemic chronic GVHD;

 -  There is GVHD under treatment;

 -  Patients with cns3 disease progression or central nervous system parenchymal lesions
 that may increase central nervous system toxicity; patients with active central
 nervous system leukemia or lymphoma infiltration;

 -  Absolute neutrophil count < 750 / μ L or platelet count < 50000 / μ l caused by non
 primary diseases;

 -  When collecting cells, they received systemic chemotherapy 2 weeks ago or radiotherapy
 3 weeks ago;

 -  Researchers believe that it is not suitable to participate in this clinical trial due
 to various reasons.