This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10\^5/kg-2.5x10\^8/kg .
Xiangya Hospital Central South University
Changsha, Hunan, China
RECRUITINGNumber of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Safety evaluation
Time frame: 60 months
Overall remission rate
Overall remission rate consists of complete remission rate and partial remission rate of patients being treated with CAR-T19/CAR-T22
Time frame: 60 months
CAR-T cells testing
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
Time frame: 60 months
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