CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* Diagnosed as CD19+ B-cell acute lymphoblastic leukemia;
* Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation;
* With an estimated survival of higher than 3 months (according to investigator's judgement);
* Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine \< 1.6 mg/dL, aspartate aminotransferase/aspartateaminotransferase \< 3 x upper limit of normal, bilirubin \<2.0 mg/dL;
* Karnofsky performance status ≥ 60 or ECOG ≤ 2.

Exclusion Criteria:

* Intolerant to immunosuppressive chemotherapies;
* With active infection or other uncontrolled complications;
* With history of seizure;
* Active hepatitis B or hepatitis C infection and HIV infection;
* Pregnant or lactating women, or patients refusing to take effective contraception measures;
* Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).

主要终点：Completeremission · defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery · 1 month post infusion；Minimal residual disease response · defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection · 1 month post infusion；Leukemia-free survival · calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up · 3 year post infusion
次要终点：Overall survival；Cumulative incidence of relapse

• CAR T-cell therapy · EXPERIMENTAL · Patients enrolled will receive infusion of CD19-targeting CART-cells

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.