Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT02813837|
Recruitment Status : Unknown
Verified June 2016 by Innovative Cellular Therapeutics Co., Ltd..
Recruitment status was: Recruiting
First Posted : June 27, 2016
Last Update Posted : June 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, B-Cell Lymphoma, B-Cell||Biological: CD19CART||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2015|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: single arm
Experimental: CD19 CART cell.The target dose range administered in this study is 1x10e5-1x10e7 CART-19 cells/kg.
Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
Other Name: CD19-directed chimeric antigen receptor modified T cells
- Occurrence of study related adverse events [ Time Frame: up to 12 months ]
- Anti-leukemia or lymphoma responses to CD19CART cell infusions [ Time Frame: up to 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813837
|Contact: Lei Xiao, Ph.D||+86-21-58950719|
|Innovative Cellular Therapeutics CO., LTD.||Recruiting|
|Contact: Lei Xiao, Ph.D +86-21-58950719|
|Principal Investigator: Yu Hu, Ph.D|
|Principal Investigator: He Huang, Ph.D|
|Study Director:||Yu Hu, Ph.D||Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology|
|Study Director:||He Huang, Ph.D||The First Affiliated Hospital of the College of Medicine, Zhejiang University|