CAR-NK cell therapy for advanced solid tumors
Official title: 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
Run by Second Affiliated Hospital of Guangzhou Medical University · NCT05410717 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | June 1, 2030 |
| Study ends | May 31, 2036 |
| Registry record updated | June 25, 2024 |
| Trial ID | NCT05410717 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with advanced ovarian cancer or other solid tumors expressing Claudin6, GPC3, Mesothelin, or AXL.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While CAR-NK cell therapies are a novel approach, similar studies targeting specific tumor markers have shown promising results in other contexts.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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OPB-201 therapy for recurrent endometrial and platinum-resistant ovarian cancer
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-
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This study is testing if using genetic information to guide treatment can help improve outcomes for people with recurrent ovarian, cervical, or endometrial cancer.
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This study is testing if a heated chemotherapy treatment followed by a drug called Niraparib can help people with advanced ovarian cancer do better after surgery compared to regular chemotherapy.
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Comparing stress reduction methods to standard care for ovarian cancer patients
This study is testing if a mix of medications and therapies can help reduce stress in women with advanced ovarian cancer before their surgery, compared to those getting standard care.
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This study is trying to find better ways to use hormonal therapy for women with advanced or recurring endometrial cancer by looking at their tumor samples to see who might benefit most from this treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.