This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).
Peking University Cancer Hospital
Beijing, China
Number of patients with adverse events
Time frame: 2 years
Treatment response rate of anti-CD19 CAR T cell infusion
Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on standardized response criteria for malignant lymphoma (Cheson BD, JCO, 2007).
Time frame: 4 weeks
overall survival rate of patients treated with anti-CD19 CAR T cells
Time frame: 2 years
progression-free survival of patients treated with anti-CD19 CAR T cells
Time frame: 2 years
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