NCT05410717RecruitingPhase 1
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 25 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 5 Jun 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Endometrial cancer, Ovarian cancer
- NCT number
- NCT05410717
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 200
- From 1 Jun 2022 to the primary completion date, 1 Jun 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had accepted gene therapy before;
- Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
Other illness
- 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;
- Other conditions that the investigators consider not appropriate. -
Other
- Tumor size more than 25cm;
- Pregnant or lactating women
Who the study is looking for
- patients with advanced ovarian cancer or other cancers with expression of claudin6.
- 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. -
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.