The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Guangdong General Hospital
Guangzhou, Guangdong, China
RECRUITINGThe maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells
Time frame: 24 weeks
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Adverse events and laboratory abnormalities (type, frequency and severity)
Time frame: 12 months
Overall Response Rate
Overall Response Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time frame: 12 months
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