CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Jun 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment called CAR-NK cell therapy for patients with advanced solid tumors, specifically stage IV ovarian cancer, testis cancer, and recurrent endometrial cancer. The goal is to see how safe this treatment is and how well it might work for patients whose tumors express certain proteins known as Claudin6, GPC3, Mesothelin, or AXL. This study is currently recruiting participants who are between 18 and 75 years old and have a life expectancy of more than 12 weeks.

To be eligible, patients must have advanced cancer that expresses Claudin6 or other targeted proteins and must meet specific health criteria, such as having good heart and kidney function. If someone joins the study, they can expect to receive this experimental therapy and will be closely monitored for any side effects and how well the treatment works. It’s important to note that people with certain health conditions, recent gene therapy, or severe infections cannot participate in this trial. If you or a loved one are considering this option, discussing it with a healthcare provider can provide more personalized information.

Gender

ALL

Eligibility 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. -