NCT03198546 GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression
| NCT ID | NCT03198546 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-07-01 |
| Primary Completion | 2029-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2017-07-01 with a primary completion date of 2029-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The third/fourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and/or soluble TGFβ (GPC3/TGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3/TGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3/TGFβ-CAR-T cell immunotherapy on human will firstly be tested.
Eligibility Criteria
Inclusion Criteria: 1. patients with advanced HCC,which express GPC3 protein. 2. Life expectancy \>12 weeks 3. Child-Pugh-Turcotte score \<7 4. Adequate heart,lung,liver,kidney function 5. 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 6. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. - Exclusion Criteria: 1. Had accepted gene therapy before; 2. Tumor size more than 25cm; 3. Severe virus infection such as HBV,HCV,HIV,et al 4. Known HIV positivity 5. History of liver transplantation 6. Active infectious disease related to bacteria, virus,fungi,et al 7. Other severe diseases that the investigators consider not appropriate; 8. Pregnant or lactating women 9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 10. Other conditions that the investigators consider not appropriate. -
Contact & Investigator
Zhenfeng Zhang, MD,PhD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT03198546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03198546 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03198546 currently recruiting?
Yes, NCT03198546 is actively recruiting participants. Contact the research team at zhangzhf@gzhmu.edu.cn for enrollment information.
Where is the NCT03198546 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China.
Who is sponsoring the NCT03198546 clinical trial?
NCT03198546 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The principal investigator is Zhenfeng Zhang, MD,PhD at Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 30 participants.
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