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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04812691
Other study ID # JWCAR029-003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 10, 2020
Est. completion date April 25, 2023

Study information

Verified date November 2023
Source Shanghai Ming Ju Biotechnology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Completed
Enrollment 12
Est. completion date April 25, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. = 18 years old; 2. Sign on the informed consent; 3. Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy; 4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 6. Adequate organ function; 7. Adequate vascular access for leukapheresis procedure; 8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; 9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; 10. 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 Exclusion Criteria: 1. Subjects who have received second-line treatment or above 2. CD19 negative 3. Primary CNS lymphoma; 4. History of another primary malignancy that has not been in remission for at least 2 years; 5. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; 6. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; 7. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; 8. Presence of acute or chronic graft-versus-host disease (GVHD); 9. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; 10. Pregnant or nursing women; 11. 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; 12. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 13. Received CAR T-cell or other genetically-modified T-cell therapy previously.

Study Design


Intervention

Biological:
JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)
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.

Locations

Country Name City State
China Zhejiang university school of medicine first affiliated hospital Hangzhou Zhejiang
China Ruijin hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Ming Ju Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Types, frequency, and severity of adverse events and laboratory anomalies Physiological parameter 2 years
Secondary Complete response rate (CRR) in primary refractory DLBCL subjects Investigator evaluated CRR in 1 month 1 month
Secondary Objective response rate (ORR) in primary refractory DLBCL subjects Investigator evaluated ORR in 1 month 1 month
Secondary 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 2 years
Secondary Investigator evaluated CRR Complete response rate (CRR) 3 months
Secondary Investigator evaluated ORR (ORR=CR+PR) Complete response (CR) + partial response(PR) 3 months
Secondary Duration of response (DOR) Time from first response(PR or CR) to disease progression or death from any cause up to 24 months after JWCAR029 infusion
Secondary Duration of complete remission (DoCR) Time from complete response (CR) to disease progression or death from any cause up to 24 months after JWCAR029 infusion
Secondary Time to response (TTR) Time from JWCAR029 infusion to first documentation of CR or PR up to 24 months after JWCAR029 infusion
Secondary Time to complete response (TTCR) Time from JWCAR029 infusion to first documentation of CR up to 24 months after JWCAR029 infusion
Secondary Pharmacokinetic (PK)- Cmax of JWCAR029 Maximum observed concentration of JWCAR029 in peripheral blood up to 1 year after JWCAR029 infusion
Secondary Pharmacokinetic (PK)- Tmax of JWCAR029 Time to maximum concentration of JWCAR029 in the peripheral blood up to 1 year after JWCAR029 infusion
Secondary Pharmacokinetic (PK)- AUC of JWCAR029 Area under the concentration vs time curve of JWCAR029 up to 1 year after JWCAR029 infusion
Secondary Progression-free survival (PFS) Progression-free survival up to 2 year after JWCAR029 infusion
Secondary Overall survival (OS) Overall survival up to 2 year after JWCAR029 infusion
Secondary Changes of CRP and serum ferritin Changes of inflammation biomarkers-CRP and serum ferritin 1 year after JWCAR029 infusion
Secondary Anti-therapeutic JWCAR029 antibody The level of anti-therapeutic JWCAR029 antibody after JWCAR029 infusion up to 2 year after JWCAR029 infusion
Secondary The concentration of Car-T cell The concentration of Car-T cells up to 2 year after JWCAR029 infusion
Secondary The proportion of Car-T cell subgroups The proportion of Car-T cell subgroups after infusion up to 2 year after JWCAR029 infusion
Secondary The concentration of CD19 in tumor biopsy samples The concentration of CD19 in tumor biopsy samples up to 2 year after JWCAR029 infusion
Secondary The change of serum cytokines concentration The change of serum cytokines concentration after JWCAR029 infusion up to 2 year after JWCAR029 infusion
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