RecruitingPhase 1

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

China200 participantsStarted 2022-06-01

Plain-language 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)

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. patients with advanced ovarian cancer or other cancers with expression of claudin6.
✓. Life expectancy \>12 weeks
✓. Adequate heart,lung,liver,kidney function
✓. 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
✓. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -

Exclusion criteria

✕. Had accepted gene therapy before;
✕. Tumor size more than 25cm;
✕. Severe virus infection such as HBV,HCV,HIV,et al
✕. Known HIV positivity
✕. History of liver/renal transplantation
✕. Active infectious disease related to bacteria, virus,fungi,et al
✕. Other severe diseases that the investigators consider not appropriate;
✕. Pregnant or lactating women

What they're measuring

Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Timeframe: After CAR-NK cells infusion, up to 52 weeks.

Trial details

NCT IDNCT05410717

SponsorSecond Affiliated Hospital of Guangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06-01

Contact for this trial

Zhenfeng Zhang, MD, PHD

+862039195966 zhangzhf@gzhmu.edu.cn

View on ClinicalTrials.gov More Stage IV Ovarian Cancer trials