NCT06253234

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

Recruiting now Phase 1 Last updated 11 February 2025

What this trial tests

Phase 1 trial testing personalized dendritic cell injection ZSNeo-DC1.1 in WHO Grade III Gliomas in 12 participants. Currently enrolling.

Timeline

2 February 2024

Primary endpoint
30 June 2025

31 December 2025

Quick facts

Lead sponsor	Beijing Tiantan Hospital
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	2 February 2024
Primary completion	30 June 2025
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• personalized dendritic cell injection ZSNeo-DC1.1 — full drug profile →

Conditions studied

• WHO Grade III Gliomas — all drugs for WHO Grade III Gliomas →
• WHO Grade IV Gliomas — all drugs for WHO Grade IV Gliomas →

Sponsor

Beijing Tiantan Hospital

Who can join

Adults 18 to 75, any sex, with WHO Grade III Gliomas or WHO Grade IV Gliomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dendritic cell subsets and implications for cancer immunotherapy.
   Chen MY, Zhang F, Goedegebuure SP, Gillanders WE. · · 2024 · cited 24× · PMID 38903502 · DOI 10.3389/fimmu.2024.1393451
2. Therapeutic approaches to modulate the immune microenvironment in gliomas.
   Sarantopoulos A, Ene C, Aquilanti E. · · 2024 · cited 19× · PMID 39443641 · DOI 10.1038/s41698-024-00717-4
3. Research and Clinical Progress of Therapeutic Tumor Vaccines.
   Dong C, Li Z, Tan D, Sun H, et al · · 2025 · cited 3× · PMID 40733649 · DOI 10.3390/vaccines13070672
4. Emerging insights into the immunosuppressive tumor microenvironment and its implications for glioblastoma immunotherapy.
   Nicolaou N, Andreou MS, Neophytou CM, Papageorgis P. · · 2025 · cited 2× · PMID 41208963 · DOI 10.3389/fimmu.2025.1665742
5. Immunologic specificity in glioblastoma: Antigen discovery and translational implications.
   Hill CM, Wang AZ, Hsueh B, Ramirez R, et al · · 2025 · cited 2× · PMID 40933038 · DOI 10.1093/noajnl/vdaf028
6. Neoantigen-driven personalized tumor therapy: An update from discovery to clinical application.
   Xie N, Shen G, Huang C, Zhu H. · · 2025 · cited 2× · PMID 40757404 · DOI 10.1097/cm9.0000000000003708
7. Recurrent Glioblastoma and the Tumor Immune Landscape: Emerging Immunotherapeutic Strategies.
   Cao Z, Tong S, Wang Z, Ji C, et al · · 2026 · PMID 41809120 · DOI 10.2147/itt.s581012
8. Immune Surveillance and Immune Escape in Cancer: Mechanisms and Immunotherapy.
   Peng Y, Zhan L, Shi J, Wang J, et al · · 2025 · PMID 41079643 · DOI 10.1002/mco2.70321