GPC3-T2-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
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ClinicalTrials.gov Identifier: NCT03198546 |
Recruitment Status :
Recruiting
First Posted : June 26, 2017
Last Update Posted : November 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Immunotherapy CAR GPC3 Gene Inactivation T Cell Squamous Cell Lung Cancer | Biological: GPC3 and/or TGFβ targeting CAR-T cells | Phase 1 |
- Choose appropriate patients with advanced hepatocellular carcinoma,with written consent for this study;
- Perform biopsy to determine the expression of GPC3 of the tumor by western blotting or IHC;
- Collect blood from the patients and isolate mononuclear cells, activate the T cells and transfect the T cells with GPC3/TGFβ targeting CAR (or/and cytokines-secreting), amplify the number of transfected T cells as needed,test the quality and killing activity of the GPC3/TGFβ-CART cells and then transplant back the patients via systemic or local injections, and follow up closely to collect related results as needed;
- Evaluate the clinical results as needed.
- Will also perform the similar clinical trial on lung squamous carcinoma with the same GPC3 expression.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma: Phase I Clinical Trial |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | August 1, 2020 |
Estimated Study Completion Date : | August 1, 2022 |

Arm | Intervention/treatment |
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CAR-T cell therapy group
Appropriate patients who could benefit from the GPC3 or or TGFβ targeting CAR-T cell therapy against HCC are chosen to be the CAR-T cell therapy group.
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Biological: GPC3 and/or TGFβ targeting CAR-T cells
Engineering GPC3 or or TGFβ targeting CAR combined with/or without IL7-CCL19 secreting vector into T cells isolated from patients with advanced HCC, and then transfusing them back the patients. |
- Number of Patients with Dose Limiting Toxicity [ Time Frame: three months ]A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-T2-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
- Percent of Patients with best response as either complete remission or partial remission. [ Time Frame: three months ]Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.
- Median CAR-T cell persistence [ Time Frame: Five years ]Median CAR-T cell persistence will be measured by quantitative rt-PCR.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients with advanced HCC,which express GPC3 protein.
- Life expectancy >12 weeks
- Child-Pugh-Turcotte score <7
- Adequate heart,lung,liver,kidney function
- Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -
Exclusion Criteria:
- Had accepted gene therapy before;
- Tumor size more than 25cm;
- Severe virus infection such as HBV,HCV,HIV,et al
- Known HIV positivity
- History of liver transplantation
- Active infectious disease related to bacteria, virus,fungi,et al
- Other severe diseases that the investigators consider not appropriate;
- Pregnant or lactating women
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
- Other conditions that the investigators consider not appropriate. -

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): NCT03198546
Contact: Zhenfeng Zhang, MD,PhD | 0086-020-34153532 | zhangzhf@gzhmu.edu.cn | |
Contact: Peng Li, PhD | +86 20 32015300 | lipeng@invivobio.com.cn |
China, Guangdong | |
The First Affiliated Hospital of Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510072 | |
Contact: Xianhong Xiang, MD,PHD | |
Contact: Yonghui Huang, MD,PHD | |
The Second Affiliated Hospital of Guangzhou Medical University | Recruiting |
Guangzhou, Guangdong, China, 510260 | |
Contact: Zhenfeng Zhang, MD,PhD +86-020-34153532 zhangzhf@gzhmu.edu.cn | |
Contact: Deji Chen, MD,PhD +86-020-34153532 chendeji2003@163.com |
Principal Investigator: | Zhenfeng Zhang, MD,PhD | Second Affiliated Hospital of Guangzhou Medical University |
Publications of Results:
Responsible Party: | Second Affiliated Hospital of Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT03198546 History of Changes |
Other Study ID Numbers: |
CAR-T on HCC |
First Posted: | June 26, 2017 Key Record Dates |
Last Update Posted: | November 26, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatocellular carcinoma immunotherapy CAR-T cell therapy GPC3 or TGFβ targeting |
Phase I clinical study squamous cell lung cancer interventional radiology IL7-CCL19-secreting |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Digestive System Diseases Liver Diseases Immunologic Factors Physiological Effects of Drugs |