Multi-4SCAR-T Therapy Targeting Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04430595|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: 4SCAR T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multiple 4SCAR-T Cell Therapy Targeting Breast Cancer|
|Estimated Study Start Date :||June 1, 2020|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Multiple 4SCAR T cells to treat breast cancer
Multiple 4SCAR T cells to treat breast cancer
Biological: 4SCAR T cells
Infusion of 4SCAR-GD2, -Her2 and -CD44v6 CAR-T cells
- Number of patients with adverse events. [ Time Frame: 3 year ]Determine the toxicity profile the multi-4SCAR-T cells with Common Toxicity Criteria for Adverse Effects version 4.0
- Anti-tumor effects [ Time Frame: 3 year ]Disease status is defined by the image scan to get the outcomes such as Complete response/remission (CR), Very good partial response/remission (VGPR), etc.
- The expansion and persistence of CAR-T cells [ 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.
- Survival time of the patients [ Time Frame: 3 year ]The survival time of the patients treated with the multi-4SCAR T cells, including progression free survival (PFS) and overall survival (OS) will be evaluated.
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): NCT04430595
|Contact: Lung-Ji Chang, PhD||+86(755)8672 firstname.lastname@example.org|
|The Seventh Affilliated Hospital, Sun Yat-Sen University||Recruiting|
|Shenzhen, Guangdong, China, 518107|
|Contact: Bo Wang, MD 86-0755-23242570 email@example.com|