CAR-NK cell therapy for advanced solid tumors
Phase I Trial to Evaluate Safety and Preliminary Efficacy of CLDN6/GPC3/Mesothelin/AXL-CAR-NK in Patients With CLDN6/GPC3/Mesothelin/AXL-positive Advanced Solid Tumors
This study is testing a new treatment using specially modified immune cells to see if they can help people with advanced solid tumors like ovarian and testis cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05410717 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and preliminary efficacy of CAR-NK cells targeting Claudin6, GPC3, Mesothelin, or AXL in patients with advanced solid tumors, including ovarian and testis cancers. Patients will undergo apheresis to collect NK cells, which will then be genetically modified to express CARs targeting specific tumor markers. The modified NK cells will be expanded and infused back into the patients, with close monitoring of their response and safety. The study aims to explore the potential of this innovative therapy in treating advanced cancers that express these targets.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced ovarian cancer or other solid tumors expressing Claudin6, GPC3, Mesothelin, or AXL.
Not a fit: Patients with severe viral infections, known HIV positivity, or those who have previously undergone gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that currently have limited effective therapies.
How similar studies have performed: While CAR-NK cell therapies are a novel approach, similar studies targeting specific tumor markers have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients with advanced ovarian cancer or other cancers with expression of claudin6. 2. Life expectancy \>12 weeks 3. Adequate heart,lung,liver,kidney function 4. Available autologous transduced NK cells with greater than or equal to 20% expression of Claudin6, GPC3, Mesothelin, or AXL-CAR determined by flow-cytometry and killing of claudin6-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. Tumor size more than 25cm; 3. Severe virus infection such as HBV,HCV,HIV,et al 4. Known HIV positivity 5. History of liver/renal 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. -
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: +862039195966
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.