Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma (EECBL)
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|ClinicalTrials.gov Identifier: NCT02728882|
Recruitment Status : Unknown
Verified March 2017 by Sinobioway Cell Therapy Co., Ltd..
Recruitment status was: Recruiting
First Posted : April 5, 2016
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: CD19-targeted CAR-T cells||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Arm, Two Phase, Multicenter Clinical Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Diffuse Large B Cell Lymphoma|
|Actual Study Start Date :||July 2, 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Experimental: single arm
Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:0 days，the first day,the fourth day,the seventh day,28 days,31 days,34 days.
Duration:Total seven times.
Biological: CD19-targeted CAR-T cells
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
- Objective Reaction Rates [ Time Frame: 0 to 180 days ]
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): NCT02728882
|Contact: Kangsheng Gu, PIfirstname.lastname@example.org|
|Contact: Yang Jiao, Investigatoremail@example.com|
|The First Affiliated Hospital of Anhui Medical University||Recruiting|
|Hefei, Anhui, China, 230022|
|Principal Investigator:||Kangsheng Gu, PI||Chief physician|