A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
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|ClinicalTrials.gov Identifier: NCT02713984|
Recruitment Status : Unknown
Verified April 2016 by Zhi Yang, Southwest Hospital, China.
Recruitment status was: Recruiting
First Posted : March 21, 2016
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Ovarian Cancer Lung Cancer Gastric Cancer Colorectal Cancer Glioma Pancreatic Cancer||Biological: Anti-HER2 CAR-T||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2019|
Experimental: HER2 positive cancers
Patients with relapsed and refractory cancer of HER2 expression will be treated with anti-HER2 CAR-T cells
Biological: Anti-HER2 CAR-T
HER-2-targeting CAR-T cells infusion in HER2 positive cancers
- Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. [ Time Frame: 3 years ]Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
- Survival time of Anti-HER2 CAR T cells in vivo. [ Time Frame: 1 year ]Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.
- Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells [ Time Frame: 12 weeks ]Evaluate the anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Related Response Criteria（iRECIST）.
- Maximum tolerated dose (MTD) of HER2 targeted CAR T cells [ Time Frame: 4 weeks ]Determine the maximum tolerated dose of each participant through the grades of side effects.
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): NCT02713984
|Contact: Cheng Qian, MD,PhDemail@example.com|
|Contact: Chengcheng Zhang, MDfirstname.lastname@example.org|
|Southwest Hospital of Third Millitary Medical University||Recruiting|
|Chongqing, Chongqing, China, 400000|
|Contact: Cheng Qian, MD,PhD 0086-023-68765461 email@example.com|
|Contact: Chengcheng Zhang, MD 0086-13883587876 firstname.lastname@example.org|
|Principal Investigator: Cheng Qian, MD,PhD|
|Sub-Investigator: Zhi Yang, PhD|
|Sub-Investigator: Chengcheng Zhang, MD|
|Principal Investigator:||Cheng Qian, MD,PhD||Southwest Hospital, China|