Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
CD19-directed CAR-T cell infusion will be given by vein
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China
RECRUITINGOccurrence of study related adverse events
defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly,likely,or definitely related to the study.
Time frame: 2 years
Response rates to CAR-T cells
Describe the response rates of patients treated with CAR-T cells, including complete remission, partial remission,stable disease and progression disease
Time frame: 2 years
Progression free survival(PFS)
Time frame: 2 years
Duration of remission(DOR)
Time frame: 2 years
Overall survival(OS) of patients treated with CAR-T cells
Time frame: 2 years
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