Actively Recruiting
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
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
200
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
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 IL7/CCL19 or scFvs against PD1/CTLA4/Lag3 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced ovarian cancer or other cancers expressing Claudin6
- Life expectancy greater than 12 weeks
- Adequate heart, lung, liver, and kidney function
- Autologous transduced NK cells with at least 20% expression of Claudin6, GPC3, Mesothelin, or AXL-CAR by flow cytometry
- Cytotoxicity assay showing at least 20% killing of Claudin6-positive targets
- Signed informed consent by patient or guardian
You will not qualify if you...
- Prior acceptance of gene therapy
- Tumor size larger than 25 cm
- Severe viral infections such as HBV, HCV, or HIV
- Known HIV positivity
- History of liver or kidney transplantation
- Active infectious diseases related to bacteria, virus, or fungi
- Other severe diseases deemed inappropriate by investigators
- Pregnant or lactating women
- Systemic steroid treatment at or above 0.5 mg prednisone equivalent per kg per day
- Other conditions considered inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks after CAR-NK cell infusion
Participants receive CLDN6, GPC3, Mesothelin, or AXL-targeting CAR-NK cell therapy, which may include genetically engineered cells secreting IL7/CCL19 or scFv against PD1/CTLA4/Lag3, and some may receive additional treatment with Cannabidiol (CBD) or NAD to enhance therapy.
Visits as needed for infusion and monitoring
Duration - Up to 36 months
Participants are closely followed to monitor safety, response, and disease control after CAR-NK cell infusion, including assessments up to 36 months for duration of response.
Visits as needed for follow-up assessments
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhenfeng Zhang, MD, PHD
B
Bingjia He, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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