Shanghai Ming Ju Biotechnology Co., Ltd.
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.
Mantle Cell Lymphoma
CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
PHASE2
This is a phase II, open-label, single-arm, multicenter study conducted in adult subjects with relapsed and refractory (R/R) mantle cell lymphoma (MCL) in China to evaluate the safety, efficacy, pharmacokinetics(PK), pharmacodynamics(PD) of JWCAR029 and immune response after JWCAR029 treatment. R/R MCL patients will be enrolled in dose level of 1.0 x 10\^8 CAR+ T cells. All subjects will be followed for 5 years following JWCAR029 infusion.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 59 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | A Phase II Open-Label, Single-Arm, Multicenter Study of JWCAR029, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma |
Actual Study Start Date : | 2021-01-13 |
Estimated Primary Completion Date : | 2023-10-25 |
Estimated Study Completion Date : | 2028-08-07 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Peking University Cancer Hospital
Beijing, Beijing, China, 100000
Not yet recruiting
Peking University Third Hospital
Beijing, Beijing, China,
Not yet recruiting
Fujian Medical University Consonancy Hospital
F U-axis, F U sauce, China,
Not yet recruiting
Guangdong Province people hospital
Guan Zhou, Guangdong, China,
Not yet recruiting
Henan Province Cancer Hospital
Zhengzhou, Henan, China,
Not yet recruiting
Jiangsu Province People Hospital
Nanjing, Jiangsu, China,
Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China,
Not yet recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai, China,
Not yet recruiting
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin, China,
Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin, China,
Not yet recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China,
Not yet recruiting
Zhejiang province Cancer Hospital
Hangzhou, Zhejiang, China,