CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells: JWCAR029 will be administered at dose level: 1 x 10\^8 CAR+T cells
Study summary
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* ≥ 18 years old;
* Sign on the informed consent;
* Subject must have histologically confirmed mantle cell lymphoma;
* Relapsed/refractory patients;
* 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;
* Expected survival is greater than 12 weeks;
* 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.
Exclusion Criteria:
* Central nervous system (CNS) only involvement by malignancy or 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, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
* Received allo-hematopoietic stem cell transplantation therapy previously.
* 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.
Primary outcome measure(s)
Objective response rate (ORR) — 3 months Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects
Trial sites (12)
Facility
City
Region
Status
Peking University Cancer Hospital
Beijing
Beijing Municipality
Peking University Third Hospital
Beijing
Beijing Municipality
Fujian Medical University Consonancy Hospital
Fuzhou
Fujiang
Guangdong Province people hospital
Guanzhou
Guangdong
Henan Province Cancer Hospital
Zhengzhou
Henan
Jiangsu Province People Hospital
Nanjing
Jiangsu
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Zhongshan Hospital affiliated to Fudan University
Shanghai
Shanghai Municipality
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
Tianjin Cancer Hospital
Tianjin
Tianjin Municipality
The First Affiliated Hospital of Zhejiang University
Hangzhou
Zhejiang
Zhejiang province Cancer Hospital
Hangzhou
Zhejiang
More Shanghai Ming Ju Biotechnology Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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