Spots Global Cancer Trial Database for Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
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Trial Identification
Brief Title: Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
Official Title: Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies
Study ID: NCT02546739
Interventions
Study Description
Brief Summary: This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
Detailed Description: This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Hebei Yanda Ludaopei Hospital, Sanhe, Hebei, China
First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Huai'An First People'S Hospital, Huaian, Jiangsu, China
Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China
First Hospital of Jilin University, Changchun, Jilin, China
Shanxi Dayi Hospital, Taiyuan, Shanxi, China
Tianjin people's hospital, Tianjin, Tianjin, China
Hangzhou Cancer Hospital, Hangzhou, Zhejiang, China
Beijing DOING Biomedical Co., Ltd, Beijing, , China
Contact Details
Name: li gangyi, master
Affiliation: Beijing Doing Biomedical Co., Ltd.
Role: STUDY_CHAIR
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