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Recruiting Phase 1 NCT05410717

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

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Plain-language summary for patients

Trial Parameters

Condition Stage IV Ovarian Cancer
Sponsor Second Affiliated Hospital of Guangzhou Medical University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2022-06-01
Completion 2030-06-01
Interventions
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells

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Brief Summary

This study is an open, exploratory clinical study to evaluate the safety and preliminary efficacy of Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells in patients with Claudin6, GPC3, Mesothelin, or AXL-positive advanced solid tumors (ovarian cancer and others)

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

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