| Eligibility |
Inclusion Criteria:
1. Relapsed and refractory CD19 positive 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. Ages 1 to 70 years, including boundary values;
5. ECOG score 0-3 points;
6. 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.
Exclusion Criteria:
1. patients with organ failure:
- Heart: NYHA heart function grade III or 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 receiving anti-GVHD treatment;
6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte
infusion(DLI);
7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1
week;
8. Central nervous system leukemias 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.
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