A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Subjects with relapsed and refractory B-cell non-Hodgkin's lymphoma would be selected if subjects meet all criteria evaluated by physical exams, blood tests, electrocardiograph, computedtomography (CT)/magnetic resonance Imaging(MRI)/positron emission tomography(PET), tumor assessments, etc. Subjects would be hospitalized to receive the infusion of CD19 CAR+ T cells after lymphodepleting regimen, with the observation and evaluation of efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A single dose of predetermined level CAR-positive T cells will be infused.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGOverall response rate (ORR) at 3 months post infusion
ORR is defined as proportion of subjects who achieved Partial remission(PR) or better at 3 months (D90±7) post infusion as assessed by an independent review committee (IRC) based on Lugano 2014 criteria.
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
DOR refers to the time from the first assessment of complete response or partial response to the first assessment of disease progression or death from any cause.
Time frame: 2 years post infusion
Progression-free Survival (PFS) after administration
PFS refers to the time from the start of cell infusion to the first assessment of tumor progression or death from any cause.
Time frame: 2 years post infusion
Overall Survival (OS) after administration
OS refers to the time from cell infusion to death due to any cause.
Time frame: 2 years post infusion
Disease control rate (DCR)
The best overall response is the ratio of partial response(PR) or complete response(CR) or stable disease(SD) patients to the total number of cases.
Time frame: 2 years post infusion
Safety evaluation
The occurrence and outcome of adverse events evaluated by physical examination, laboratory examination, electrocardiogram, imaging scan, etc.
Time frame: 2 years post infusion
Pharmacokinetic (PK) parameters: Maximum CAR level inperipheral blood
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The highest concentration of Human CD19 Targeted T Cells Injection amplified in peripheral blood after infusion (Cmax) .
Time frame: 2 years post infusion
Pharmacokinetics(PK) parameters: Time to peak CAR level in blood (Tmax)
The time to reach the highest concentration of Human CD19 Targeted T Cells Injection in peripheral blood after infusion (Tmax) .
Time frame: 2 years post infusion
Pharmacokinetics(PK) parameters: 28-day Area under the curve of the CAR level in blood(AUC0-28)
The 28-day area under the curve of Human CD19 Targeted T Cells Injection in peripheral blood after infusion(AUC0-28d).
Time frame: 2 years post infusion
Pharmacodynamic (PD) parameters
The clearance degree of CD19 positive B cells in peripheral blood at respective time point.
Time frame: 2 years post infusion