NK-92MI Cells Engineered with Anti-claudin-6 Chimeric Antigen Receptors in Immunotherapy for Ovarian Cancer.
Junping Li, Hong Hu, Hui Lian...
https://pubmed.ncbi.nlm.nih.gov/38481806/Actively Recruiting
Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25
200
Participants Needed
1
Research Sites
313 weeks
Total Duration
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
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors
Z
Zhenfeng Zhang, MD, PHD
B
Bingjia He, MD
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Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor
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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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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Junping Li, Hong Hu, Hui Lian...
https://pubmed.ncbi.nlm.nih.gov/38481806/Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor