NCT06156150

The Role of B7-H4 in Tumor Vaccine

Recruiting now Last updated 5 December 2023

What this trial tests

trial testing tumor vaccine in Glioma in 160 participants. Currently enrolling.

Timeline

26 November 2023

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Huashan Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	160
Start date	26 November 2023
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• tumor vaccine — full drug profile →

Conditions studied

• Glioma — all drugs for Glioma →

Sponsor

Huashan Hospital

Who can join

Adults 18 to 80, any sex, with Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Glioma patients have poor prognosis because of limited choices of treatment. Therapeutic cancer vaccines have been proved to improve survival in glioma, but resistance is a new challenge for vaccine treatment, and the mechanism is unclear. The applicant found in previous papers that glioma cells induced B7-H4 overexpression in macrophages, and the expression level of B7-H4 is highly correlated with vaccine resistance. Preliminary experiments indicated that B7-H4 protein in macrophages inhibited the expression of ATF3, STAT1 and CXCL9/10, which also resulted in decreased T cell infiltration in glioma model of mouse and was a negative factor of vaccine benefits. Therefore, the applicant hypothesize that B7-H4 inhibits STAT1 transcription by reducing expression of ATF3, resulting in decreased phosphorylated-STAT1 in nucleus, which inhibiting expression and secretion of chemokines 9/10. Thereby, reduced infiltration of T cells in microenvironment will be followed, which ultimately promotes resistance of vaccine treatment in glioma. The follow-up plan of this project will be conducted based on the cells, organoid platform and animal experiments to confirm the role and mechanism of macrophage-derived B7-H4 in secretion of chemokines for T cells and treatment resistance of vaccines. Moreover, the DC vaccine produced by team of the applicant will be used to assess the probability of reversing vaccine resistance when intervening B7-H4 axis. Finally, a model for evaluating clinical benefits from vaccine will be established based on data from clinical trials combining with expression of B7-H4 and clinicopathologic features. This study will provide new evidences for the treatment of cancer vaccines in gliomas.

Publications & conference data

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

1. Trial watch: anticancer vaccination with dendritic cells.
   Borges F, Laureano RS, Vanmeerbeek I, Sprooten J, et al · · 2024 · cited 18× · PMID 39398476 · DOI 10.1080/2162402x.2024.2412876
2. Tumor organoids in immunotherapy: from disease modeling to translational research.
   Si Q, Tao S, Wu J, Ma J, et al · · 2025 · cited 5× · PMID 40664453 · DOI 10.1136/jitc-2025-011733
3. Immune organoid for cancer immunotherapy.
   Wang XH, Wang WY, Sun ZJ. · · 2025 · cited 2× · PMID 40698131 · DOI 10.1016/j.apsb.2025.04.031
4. Tumor Organoid and Microenvironment Cocultures: Implications for Basic and Translational Cancer Research.
   Yang J, Cheng C, Luo W, He X, et al · · 2026 · PMID 41987851 · DOI 10.1002/mco2.70741
5. Recapitulating the tumour microenvironment: advancing personalised radiation therapy through organoid technology.
   Lan Z, Liu J, Li L, Yang Y, et al · · 2026 · PMID 41761263 · DOI 10.1186/s13046-026-03655-0