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Brief Title: Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies
Official Title: A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01)
Study ID: NCT02813837
Brief Summary: This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.
Detailed Description: This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Innovative Cellular Therapeutics CO., LTD., Shanghai, , China
Name: Yu Hu, Ph.D
Affiliation: Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
Role: STUDY_DIRECTOR
Name: He Huang, Ph.D
Affiliation: The First Affiliated Hospital of the College of Medicine, Zhejiang University
Role: STUDY_DIRECTOR