NCT05410717 CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid Tumors
| NCT ID | NCT05410717 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Stage IV Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2022-06-01 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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. -
Contact & Investigator
Zhenfeng Zhang, MD, PHD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT05410717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stage IV Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05410717 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05410717 currently recruiting?
Yes, NCT05410717 is actively recruiting participants. Contact the research team at zhangzhf@gzhmu.edu.cn for enrollment information.
Where is the NCT05410717 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05410717 clinical trial?
NCT05410717 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The principal investigator is Zhenfeng Zhang, MD, PHD at Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 200 participants.
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