NCT06682117

A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.

Detailed description

This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors (especially head and neck cancer, non-driver gene sensitive mutation of non-small cell lung cancer). The investigators plan to enroll about 9 patients to explore the dose limited toxicity or recommended dose for future study of Neo-DC vaccine. The study is designed as 3 plus 3 model, and set two dose levels.

Conditions

• Treatment
• Neoantigen
• Vaccine
• Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	DC Vaccine	Patients will receive Neo-DC vaccine infusion either by dose 1 (1×10\^7 cells/time) or dose 2 (5×10\^7 cells/time) every 7 days, four cell infusions are one treatment cycle. The dose limited toxity observation time is within 28 days after the first Neo-DC vaccine infusion. If the efficacy is evaluated as clinical benefit (CR/PR/SD) or immune unconfirmed progress ( iUPD), treatment cycle can be continued until the completion of four Neo-DC vaccine administrations or disease progression (iCPD by iRECIST) or start new anti-tumor treatment or stop treatment by other reasons.

Timeline

• Start date: 2024-11-15
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-11-12
• Last updated: 2026-04-02

Locations

1 site across 1 country: China