CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients

This is an interventional treatment trial for B-cell Leukemia Read More

Inclusion Criteria:

1. Relapsed and refractory B-cell acute malignancies with:

   • Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
   • MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
   • Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
3. Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
4. Double positive expression of CD19 / CD20 in B cells;
5. Ages 1 to 70 years, including boundary values;
6. ECOG score 0-3 points;
7. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
8. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

Exclusion Criteria:

1. patients with organ failure:

   • Heart: NYHA heart function grade IV;
   • Liver: Grade C that achieves Child-Turcotte liver function grading;
   • Kidney: kidney failure and uremia;
   • Lung: symptoms of respiratory failure;
   • Brain: a person with a disability;
2. Active infections that are difficult to control;
3. Human immunodeficiency virus (HIV) positive;
4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL / min;
5. GVHD ≥ 2 or anti-GVHD treatment;
6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion;
7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
8. Central nervous system white blood that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL);
9. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
10. pregnant or lactating women;
11. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
12. Patients who participate in other clinical studies at the same time;
13. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.