CAR-T Cell Immunotherapy in MUC1 Positive Solid Tumor
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|ClinicalTrials.gov Identifier: NCT02617134|
Recruitment Status : Unknown
Verified July 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 30, 2015
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma of Brain Colorectal Carcinoma Gastric Carcinoma||Biological: anti-MUC1 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:||Immunotherapy With Chimeric Antigen Receptor-Modified T Cells for MUC1 Positive Advanced Refractory Solid Tumor|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2018|
Experimental: CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
Biological: anti-MUC1 CAR-T cells
Other Name: anti-MUC1-CAR transduced autologous T cells
- Adverse events attributed to the administration of the anti-MUC1 CAR-T cells [ Time Frame: 2 years ]Determine the toxicity profile of the MUC1 targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-T infusion. ]The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
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): NCT02617134
|Contact: Lin Yang, Ph.D.||firstname.lastname@example.org|
|PersonGen Biomedicine (Suzhou) Co., Ltd.||Recruiting|
|Suzhou, Jiangsu, China, 215123|
|Contact: Lin Yang, Ph.D. 86-512-65922190 email@example.com|
|Principal Investigator: Yangyi Bao, MD|
|Principal Investigator: Xiang Sun, MD|
|Principal Investigator: Lin Yang, Ph.D.|
|Principal Investigator:||Lin Yang, Ph.D.||PersonGen BioTherapeutics (Suzhou) Co., Ltd.|