CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Biological: JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)
- Registration Number
- NCT04812691
- Lead Sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- ≥ 18 years old;
- Sign on the informed consent;
- Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy;
- Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Adequate organ function;
- Adequate vascular access for leukapheresis procedure;
- Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
- Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
- Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029
- Subjects who have received second-line treatment or above
- CD19 negative
- Primary CNS lymphoma;
- History of another primary malignancy that has not been in remission for at least 2 years;
- Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
- Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
- Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
- Presence of acute or chronic graft-versus-host disease (GVHD);
- History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
- Pregnant or nursing women;
- Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
- Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
- Received CAR T-cell or other genetically-modified T-cell therapy previously.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JWCAR029 JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells) The safety and efficacy of JWCAR029 will be evaluated in 1 x 10\^8 CAR+T cells dose level
- Primary Outcome Measures
Name Time Method Types, frequency, and severity of adverse events and laboratory anomalies 2 years Physiological parameter
- Secondary Outcome Measures
Name Time Method Complete response rate (CRR) in primary refractory DLBCL subjects 1 month Investigator evaluated CRR in 1 month
Duration of response (DOR) up to 24 months after JWCAR029 infusion Time from first response(PR or CR) to disease progression or death from any cause
Time to response (TTR) up to 24 months after JWCAR029 infusion Time from JWCAR029 infusion to first documentation of CR or PR
Progression-free survival (PFS) up to 2 year after JWCAR029 infusion Progression-free survival
Best objective response rate (BORR) 2 years The best response from the onset of treatment to the onset of disease progression/recurrence or to the onset of another anticancer treatment
Pharmacokinetic (PK)- AUC of JWCAR029 up to 1 year after JWCAR029 infusion Area under the concentration vs time curve of JWCAR029
Objective response rate (ORR) in primary refractory DLBCL subjects 1 month Investigator evaluated ORR in 1 month
Investigator evaluated ORR (ORR=CR+PR) 3 months Complete response (CR) + partial response（PR）
Duration of complete remission (DoCR) up to 24 months after JWCAR029 infusion Time from complete response (CR) to disease progression or death from any cause
Pharmacokinetic (PK)- Cmax of JWCAR029 up to 1 year after JWCAR029 infusion Maximum observed concentration of JWCAR029 in peripheral blood
Pharmacokinetic (PK)- Tmax of JWCAR029 up to 1 year after JWCAR029 infusion Time to maximum concentration of JWCAR029 in the peripheral blood
Changes of CRP and serum ferritin 1 year after JWCAR029 infusion Changes of inflammation biomarkers-CRP and serum ferritin
The concentration of CD19 in tumor biopsy samples up to 2 year after JWCAR029 infusion The concentration of CD19 in tumor biopsy samples
The change of serum cytokines concentration up to 2 year after JWCAR029 infusion The change of serum cytokines concentration after JWCAR029 infusion
Anti-therapeutic JWCAR029 antibody up to 2 year after JWCAR029 infusion The level of anti-therapeutic JWCAR029 antibody after JWCAR029 infusion
Investigator evaluated CRR 3 months Complete response rate (CRR)
Time to complete response (TTCR) up to 24 months after JWCAR029 infusion Time from JWCAR029 infusion to first documentation of CR
Overall survival (OS) up to 2 year after JWCAR029 infusion Overall survival
The concentration of Car-T cell up to 2 year after JWCAR029 infusion The concentration of Car-T cells
The proportion of Car-T cell subgroups up to 2 year after JWCAR029 infusion The proportion of Car-T cell subgroups after infusion
Trial Locations
- Locations (2)
Ruijin hospital
🇨🇳Shanghai, Shanghai, China
Zhejiang university school of medicine first affiliated hospital
🇨🇳Hangzhou, Zhejiang, China