Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 1
Started
2022-06-01
Last updated
2024-06-25
Condition(s) studied
Stage IV Ovarian CancerTestis Cancer, RefractoryEndometrial Cancer RecurrentCAR NK
Investigational drug(s) / intervention(s)
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells
Claudin6, GPC3, Mesothelin, or AXL targeting CAR-NK cells: Engineering Claudin6, GPC3, Mesothelin, or AXL targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Lag3 secreting vector into NK cells, which are isolated from patients with advanced ovarian cancer or other cancers with expression of Claudin6, GPC3, Mesothelin, or AXL, and then transfusing them back the patients.
In some cases, the CAR-NK cells will be combined with CBD or NAD to enhance the therapeutic efficacy.
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. patients with advanced ovarian cancer or other cancers with expression of claudin6.
2. Life expectancy \>12 weeks
3. Adequate heart,lung,liver,kidney function
4. 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
5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. -
Exclusion Criteria:
1. Had accepted gene therapy before;
2. Tumor size more than 25cm;
3. Severe virus infection such as HBV,HCV,HIV,et al
4. Known HIV positivity
5. History of liver/renal transplantation
6. Active infectious disease related to bacteria, virus,fungi,et al
7. Other severe diseases that the investigators consider not appropriate;
8. Pregnant or lactating women
9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
10. Other conditions that the investigators consider not appropriate. -
Primary outcome measure(s)
Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 — 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.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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