GPC3-T2-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03198546|
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : November 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|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)|
|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|
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.
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.
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,PhDfirstname.lastname@example.org|
|Contact: Peng Li, PhD||+86 20 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Deji Chen, MD,PhD +86-020-34153532 email@example.com|
|Principal Investigator:||Zhenfeng Zhang, MD,PhD||Second Affiliated Hospital of Guangzhou Medical University|