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
Phase 2
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 2 years following JWCAR029 infusion.
Study Type : | Interventional |
Estimated Enrollment : | 59 participants |
Masking: | None (Open Label) |
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 : | January 13, 2021 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | June 30, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: JWCAR029 treatment JWCAR029 be administrated at dose level: 1 x 10^8 CAR+T cells |
Biological: CD19-targeted Chimeric Antigen Receptor (CAR) T Cells |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Peking University Cancer Hospital
Beijing, Beijing, China, 100000
Recruiting
Peking University Third Hospital
Beijing, Beijing, China,
Recruiting
Fujian Medical University Consonancy Hospital
Fuzhou, Fujiang, China,
Recruiting
Guangdong Province people hospital
Guanzhou, Guangdong, China,
Recruiting
Henan Province Cancer Hospital
Zhengzhou, Henan, China,
Recruiting
Jiangsu Province People Hospital
Nanjing, Jiangsu, China,
Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China,
Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai, China,
Recruiting
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin, China,
Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin, China,
Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China,
Recruiting
Zhejiang province Cancer Hospital
Hangzhou, Zhejiang, China,