Humanized CAR-T Therapy for Treatment of B Cell Malignancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02782351|
Recruitment Status : Unknown
Verified August 2017 by Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University.
Recruitment status was: Recruiting
First Posted : May 25, 2016
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphocytic, Chronic, B-Cell||Biological: CAR-T||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
- CAR-T cells persistence in peripheral blood [ Time Frame: 12 months ]The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR
- B cell number and immunoglobulins in peripheral blood [ Time Frame: 12 months ]The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods
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): NCT02782351
|Contact: Jiang Cao, M.D., Ph.D.||firstname.lastname@example.org|
|Contact: JunNian Zheng, M.D., Ph.D.|
|Huaian First People's Hospital||Recruiting|
|Huai'an, Jiangsu, China, 223300|
|Contact: Chunling Wang, M.D., Ph.D.|
|Affiliated hospital of Xuzhou medical college||Recruiting|
|Xuzhou, Jiangsu, China, 221000|
|Contact: Jiang Cao, M.D., Ph.D.|
|Principal Investigator:||KaiLin Xu, MD. Ph.D.||Xuzhou Medical University|