The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
T cells modified with CD19 targeted chimeric antigen receptor.
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGAdverse events of each patient.
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time frame: 3 years
Survival time of Anti-CD19 CAR T cells in vivo.
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Time frame: 3 years
Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells
Time frame: 12 weeks
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
To confirm the maximum tolerated dose of CD19 targeted CAR T cells.
Time frame: 4 weeks
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