NCT06253234

Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas

Phase I Clinical Trial of Personalized Dendritic Cell Injection ZSNeo-DC1.1 in the Treatment of Recurrent or Progressive High-grade Glioma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. The subjects are adult GBM patients who have undergone surgical resection for recurrence. After the completion of reoperation, subjects will receive autologous DC vaccine treatments as scheduled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.h) to subjects. After 3 injections, the investigator will review subject's tolerance and compliance. The DLT observation period spans from the initial injection to 21 days after the third injection, aligning with the activation of anti-tumor immune response. About 15 subjects will be enrolled. The study utilizes a fixed dose of 1×10\^7 cells per injection and employs two immunization schedules A or B. The trial is conducted in two stages: Dose Confirmation Stage: Enrollment of six subjects with recurrent or progressive gliomas following standard treatment. Each subject receives six subcutaneous injections of ZSNeo-DC1.1. Utilization of a standard "3+3" design for fixed dose confirmation and exploration of immunization schedules A and B. Dose Expansion Stage: Enrollment of at least six subjects with recurrent or progressive gliomas post-standard treatment. Administration of six subcutaneous injections of ZSNeo-DC1.1 to each subject, further investigating the safety and preliminary efficacy of ZSNeo-DC1.1 injection.

Conditions

• WHO Grade III Gliomas
• WHO Grade IV Gliomas

Interventions

Type	Name	Description
BIOLOGICAL	personalized dendritic cell injection ZSNeo-DC1.1	Sequence A: For the first 3 cycles, 1 week as a dosing cycle, the next 3 cycles, 3 weeks as a dosing cycle, a total of 6 dosing cycles Sequence B: For the first 3 cycles, 1 week as a dosing cycle, the next 3 cycles, 2 weeks as a dosing cycle, a total of 6 dosing cycles

Timeline

• Start date: 2024-02-02
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-02-12
• Last updated: 2025-02-11

Locations

1 site across 1 country: China