CAR-γδT cell therapy targeting GPC3 and Mesothelin for cancer treatment
GPC3/Mesothelin Targeted CAR-γδT for Immunotherapy of Solid Cancer: Phase I Clinical Trial
This study is testing a new cancer treatment that uses modified immune cells to target specific proteins in patients with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06196294 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial evaluates the safety, tolerance, and preliminary efficacy of GPC3/Mesothelin-CAR-γδT cell immunotherapy in patients with advanced solid tumors expressing GPC3 or Mesothelin. Patients will undergo biopsy to confirm protein expression, followed by the isolation and transfection of their γδT cells with CAR targeting these proteins. The modified cells will be reintroduced into the patients, potentially alongside immune checkpoint inhibitors, to enhance their anti-cancer activity. The study aims to gather data on the clinical outcomes and safety of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced cancers that express GPC3 or Mesothelin and have a life expectancy of more than 12 weeks.
Not a fit: Patients with prior gene therapy, severe viral infections, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and effective treatment option for patients with advanced cancers that express GPC3 or Mesothelin.
How similar studies have performed: While CAR-T cell therapies have shown success in various cancers, this specific approach using CAR-γδT cells targeting GPC3 and Mesothelin is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Patients with advanced cancer that expresses GPC3 or Mesothelin protein; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3/Mesothelin-CAR determined by flow-cytometry and killing of Mesothelin-positive targets greater than or equal to 20% in cytotoxicity assay; 5. 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. Severe virus infection such as HBV, HCV, HIV, et al; 3. Known HIV positivity; 4. Active infectious disease related to bacteria, virus,fungi,et al; 5. Other severe diseases that the investigators consider not appropriate; 6. Pregnant or lactating women; 7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. Other conditions that the investigators consider not appropriate. -
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Zhenfeng Zhang, MD, PhD
- Email: zhangzhf@gzhmu.edu.cn
- Phone: 0086-020-39195965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.