CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
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|ClinicalTrials.gov Identifier: NCT03146533|
Recruitment Status : Unknown
Verified April 2017 by Shenzhen Second People's Hospital.
Recruitment status was: Recruiting
First Posted : May 10, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma||Drug: Fludarabine Drug: Cyclophosphamide Biological: CD19 CART||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: CD19 CART
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.
Fludarabine 30 mg/m2/day IV for 3 days.
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.
Biological: CD19 CART
CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
- safety as assessed by the occurence of study related adverse events [ Time Frame: 6 months ]monitor the occurence of study related adverse events
- observe the maximum tolerated dose (MTD) [ Time Frame: 2 months ]
- objective response rate [ Time Frame: 2 years ]CR+PR
- disease control rate [ Time Frame: 2 years ]CR+PR+SD
- overall survival [ Time Frame: 2 years ]OS
- Progression-Free Survival [ Time Frame: 2 years ]
- Determine duration of in vivo survival of CD19 CART cells [ Time Frame: 2 years ]CD19 CART vector sequences will be performed by Q-PCR
- Peripheral blood cytokines [ Time Frame: 2 months ]IL-6、IL-10、IFN-γ、TNF-α
- subgroup of T cell [ Time Frame: 2 years ]CD3、CD4、CD8
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): NCT03146533
|Contact: geng email@example.com|
|The Second People's Hospital of Shenzhen||Recruiting|
|Shenzhen, Guangdong, China|
|Contact: geng tian 13724395569 firstname.lastname@example.org|
|Principal Investigator: geng tian|
|Principal Investigator:||geng tian||Shenzhen Second People's Hospital|