CAR-T cell therapy targeting mesothelin for cancer treatment
Mesothelin/GPC3/GUCY2C Targeted CAR-T for Immunotherapy of Pancreatic Cancer: Phase I Clinical Trial
This study is testing a new CAR-T cell therapy that targets a specific protein in advanced cancers, like pancreatic cancer, to see if it can help patients feel better and fight their disease.
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, CAR-T, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05779917 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a second-generation CAR-T cell therapy designed to target mesothelin, a protein often expressed in advanced pancreatic and other cancers. Patients with advanced cancer will undergo a biopsy to confirm mesothelin expression, followed by the collection and modification of their T cells to create mesothelin-targeting CAR-T cells. These modified cells will be reintroduced into the patients, potentially in combination with immune checkpoint inhibitors, to assess safety, tolerance, and preliminary efficacy in treating their cancers.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced pancreatic cancer or other cancers that express 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 expressing mesothelin.
How similar studies have performed: Other studies utilizing CAR-T cell therapies have shown promising results, indicating potential for success with this novel approach targeting mesothelin.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Patients with advanced cancer that expresses 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 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.