Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
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|ClinicalTrials.gov Identifier: NCT03356782|
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Osteoid Sarcoma Ewing Sarcoma||Biological: Sarcoma-specific CAR-T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Sarcoma-specific CAR-T cells
Peripheral blood mononuclear cells (PBMCs) of patients who have CD133, GD2, Muc1, CD117 or other marker positive sarcoma will be obtained through apheresis, and T cells will be activated and modified to sarcoma-specific CAR-T cells.
Biological: Sarcoma-specific CAR-T cells
1 infusion, for 1x10^6~1x10^7 cells/kg via IV
- Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 3 months ]Physiological parameter (measuring cytokine response)
- Persistence and proliferation of CART cells in patients [ Time Frame: 3 months ]The expansion and functional persistence of CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
- Anti-tumor effects [ Time Frame: 1 year ]Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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): NCT03356782
|Contact: Lung-Ji Chang, PhDfirstname.lastname@example.org|
|Shenzhen Geno-immune Medical Institute||Recruiting|
|Shenzhen, Guangdong, China, 518000|
|Contact: Lung-Ji Chang, PhD 86-075586725195 email@example.com|
|Principal Investigator:||Lung-Ji Chang, PhD||Shenzhen Geno-Immune Medical Institute|