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Phase 1
Age: 18Years - 75Years
All Genders
ID05410717

Phase 1 Study of Claudin6, GPC3, Mesothelin, or AXL-Targeting CAR-NK Cell Therapy for Advanced Solid Tumors Including Ovarian Cancer

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25

200

Participants Needed

1

Research Sites

313 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and early effectiveness of CAR-NK cell therapies targeting Claudin6, GPC3, Mesothelin, or AXL in patients with advanced solid tumors, including ovarian cancer. The study focuses on patients whose tumors express these specific markers and explores different genetic modifications to enhance the anti-cancer activity of the CAR-NK cells. This is an open, exploratory Phase 1 clinical trial conducted by the Second Affiliated Hospital of Guangzhou Medical University. Participants will undergo a procedure to collect their natural killer NK cells, which are then engineered to carry CARs targeting Claudin6, GPC3, Mesothelin, or AXL. Some CAR-NK cells are further engineered to secrete IL7CCL19 or scFvs against PD1CTLA4Lag3 to boost effectiveness. Others may be combined with cannabidiol CBD or nicotinamide adenine dinucleotide NAD. Patients receive these modified cells via systemic or local infusions, and similar therapies are tested across different cancer types expressing these markers. During the study, patients are closely monitored for safety according to standard criteria for adverse events for up to 52 weeks after infusion. Researchers will also assess tumor response rates, disease control, and duration of response for up to three years. Quality and activity of the infused CAR-NK cells are tested before administration. Follow-up includes clinical evaluations and laboratory testing to track treatment effects and safety throughout the trial.

CONDITIONS

Brief Title

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

Research Team

Z

Zhenfeng Zhang, MD, PHD

B

Bingjia He, MD

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