B-ALL
Conditions
Interventions
experimental group:Intravenous infusion of STAR-T cells
Sponsors
Hebei Yanda Ludaopei Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
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. Aged 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. 7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.
Exclusion criteria
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 x ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 x 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE; | — |
Secondary
| Measure | Time frame |
|---|---|
| CR;PR;T cell proliferation;T cell persistence; | — |
Countries
China
Contacts
Public ContactXian Zhang
Outcome results
None listed