This is a phase I, open-label, single-arm, multicenter study to assess the safety and efficacy of JWCAR029 in adult primary refractory DLBCL subjects in China
This is a phase I, open-label, single-arm, multicenter study conducted in adult subjects with primary refractory DLBCL in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and collect immune response after JWCAR029 treatment. One dose level of 1.0 x 10\^8 CAR+ T cells is adopted in this study. All sujects will be followed for 2 years after JWCAR029 infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10\^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.
Ruijin hospital
Shanghai, Shanghai Municipality, China
Zhejiang university school of medicine first affiliated hospital
Hangzhou, Zhejiang, China
Types, frequency, and severity of adverse events and laboratory anomalies
Physiological parameter
Time frame: 2 years
Complete response rate (CRR) in primary refractory DLBCL subjects
Investigator evaluated CRR in 1 month
Time frame: 1 month
Objective response rate (ORR) in primary refractory DLBCL subjects
Investigator evaluated ORR in 1 month
Time frame: 1 month
Best objective response rate (BORR)
The best response from the onset of treatment to the onset of disease progression/recurrence or to the onset of another anticancer treatment
Time frame: 2 years
Investigator evaluated CRR
Complete response rate (CRR)
Time frame: 3 months
Investigator evaluated ORR (ORR=CR+PR)
Complete response (CR) + partial response(PR)
Time frame: 3 months
Duration of response (DOR)
Time from first response(PR or CR) to disease progression or death from any cause
Time frame: up to 24 months after JWCAR029 infusion
Duration of complete remission (DoCR)
Time from complete response (CR) to disease progression or death from any cause
Time frame: up to 24 months after JWCAR029 infusion
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Time to response (TTR)
Time from JWCAR029 infusion to first documentation of CR or PR
Time frame: up to 24 months after JWCAR029 infusion
Time to complete response (TTCR)
Time from JWCAR029 infusion to first documentation of CR
Time frame: up to 24 months after JWCAR029 infusion
Pharmacokinetic (PK)- Cmax of JWCAR029
Maximum observed concentration of JWCAR029 in peripheral blood
Time frame: up to 1 year after JWCAR029 infusion
Pharmacokinetic (PK)- Tmax of JWCAR029
Time to maximum concentration of JWCAR029 in the peripheral blood
Time frame: up to 1 year after JWCAR029 infusion
Pharmacokinetic (PK)- AUC of JWCAR029
Area under the concentration vs time curve of JWCAR029
Time frame: up to 1 year after JWCAR029 infusion
Progression-free survival (PFS)
Progression-free survival
Time frame: up to 2 year after JWCAR029 infusion
Overall survival (OS)
Overall survival
Time frame: up to 2 year after JWCAR029 infusion
Changes of CRP and serum ferritin
Changes of inflammation biomarkers-CRP and serum ferritin
Time frame: 1 year after JWCAR029 infusion
Anti-therapeutic JWCAR029 antibody
The level of anti-therapeutic JWCAR029 antibody after JWCAR029 infusion
Time frame: up to 2 year after JWCAR029 infusion
The concentration of Car-T cell
The concentration of Car-T cells
Time frame: up to 2 year after JWCAR029 infusion
The proportion of Car-T cell subgroups
The proportion of Car-T cell subgroups after infusion
Time frame: up to 2 year after JWCAR029 infusion
The concentration of CD19 in tumor biopsy samples
The concentration of CD19 in tumor biopsy samples
Time frame: up to 2 year after JWCAR029 infusion
The change of serum cytokines concentration
The change of serum cytokines concentration after JWCAR029 infusion
Time frame: up to 2 year after JWCAR029 infusion