NCT05410717RecruitingPhase 1
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
Second Affiliated Hospital of Guangzhou Medical University1 site in 1 country200 target enrollmentStarted: June 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Study Overview
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)
Detailed Description
- Choose appropriate advanced cancer patients with Claudin6, GPC3, Mesothelin, or AXL expression, with written consent for the study;
- Perform PBMCs apheresis from the patient and isolate NK cells, transfect the NK cells with Claudin6, GPC3, Mesothelin, or AXL targeting CAR, amplify the number of transfected NK cells as needed, test the quality and killing activity of the Claudin6, GPC3, Mesothelin, or AXL-CAR-NK cells and then transplant back the patients via systemic or local infusions (via artery or intra-tumor), and follow up closely to collect related results as needed;
- To enhance the killing capability, some CAR-NK cells are genetically engineered to express and secret IL7/CCL19 and/or SCFVs against PD1/CTLA4/Lag3; some CAR-NK cells are combined with Cannabidiol(CBD) or Nicotinamide adenine dinucleotide (NAD);
- Evaluate the clinical results as needed.
- Will also perform the similar clinical trial on different cancer types with Claudin6, GPC3, Mesothelin, or AXL expression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with advanced ovarian cancer or other cancers with expression of claudin
- •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
- •Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
- •Other conditions that the investigators consider not appropriate. -
Outcomes
Primary Outcomes
Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time Frame: After CAR-NK cells infusion, up to 52 weeks.
The type, frequency, severity, and duration of adverse events as a result of Claudin6, GPC3, Mesothelin, or AXL- CAR-NK cells infusion will be summarized.
Secondary Outcomes
- Objective Response Rate (ORR)(After CAR-NK cells infusion, up to 52 weeks.)
- Duration of response (DOR)(up to 36 months)
- Disease control rate (DCR)(up to 52 weeks.)
Investigators
Study Sites (1)
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