A single arm, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
ThisCART19 cell is a non-gene-editing allogeneic CAR-T cell targeting CD19. This study is designed to evaluate the safety and clinical activity of ThisCART19 in patients with CD19 positive, relapsed and/or refractory non-Hodgkin's B cell lymphoma (r/r B-NHL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
0.2-60 x 10\^6 CAR T cells per kg body weight
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGTreatment related adverse events
Incidence and severity of adverse events as assessed by NCI-CTCAE 5.0
Time frame: 90 days post infusion
Overall Remission Rate (ORR)
Anti-tumor efficacy by 2014 Lugano criteria
Time frame: up to 90 days
Progression free survival time
The interval between administration and disease progression or death
Time frame: 3 years
Overall survival time
The interval between administration and death caused by any reason
Time frame: 3 years
Event-free survival (EFS)
EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.
Time frame: 3 years
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