A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
|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: NCT02713984|
Recruitment Status : Withdrawn (Reform CAR structure due to safety consideration)
First Posted : March 21, 2016
Last Update Posted : March 19, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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)|
|Actual Enrollment :||0 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|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Relapsed or refractory HER2 positive cancer.
- Life expectancy>3 months.
- Gender unlimited, age from 18 years to 80 years.
- Assessable lesions with a minimum size of 10mm by CT scan or MRI.
Acceptable organ function
- Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
- White blood cell (WBC) (> 2000/mm^3).
- Platelet count greater than 50,000/mm^3.
- Hemoglobin greater than 9.0 g/dl.
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
- Serum creatinine less or equal to 3 times the upper limit of normal
- Total bilirubin less than or equal to 3 times the upper limit of normal.
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- Adequate cardiac function(LVEF≥40%).
- No other tumors.
- Patients volunteer to participate in the research.
- Allergic to cytokines.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- HIV affected.
- Other situations improper for the research.
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
|Southwest Hospital of Third Millitary Medical University|
|Chongqing, Chongqing, China, 400000|
|Principal Investigator:||Cheng Qian, MD,PhD||Southwest Hospital, China|
|Responsible Party:||Zhi Yang, Researcher of Biotherpy Center, Southwest Hospital, China|
|Other Study ID Numbers:||
|First Posted:||March 21, 2016 Key Record Dates|
|Last Update Posted:||March 19, 2020|
|Last Verified:||March 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
refractory and relapsed cancer