NCT06305910

CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults

Recruiting now Phase 1 Last updated 12 March 2024

What this trial tests

Phase 1 trial testing Treatment with CD200AR-L in Diffuse Midline Glioma, H3 K27M-Mutant in 24 participants. Currently enrolling.

Timeline

15 March 2024

Primary endpoint
15 September 2025

15 January 2027

Quick facts

Lead sponsor	OX2 Therapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	15 March 2024
Primary completion	15 September 2025
Estimated completion	15 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Treatment with CD200AR-L — full drug profile →

Conditions studied

• Diffuse Midline Glioma, H3 K27M-Mutant — all drugs for Diffuse Midline Glioma, H3 K27M-Mutant →
• Recurrent High Grade Glioma — all drugs for Recurrent High Grade Glioma →

Sponsor

OX2 Therapeutics — full company profile →

Who can join

Adults 2 to 25, any sex, with Diffuse Midline Glioma, H3 K27M-Mutant or Recurrent High Grade Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single center Phase I study of a new adjuvant CD200 activation receptor ligand, CD200AR-L, in combination with imiquimod and GBM6-AD vaccine to treat malignant glioma in children and young adults.

The primary objective of this study is to determine the maximum tolerated dose (MTD) of CD200AR-L when given with a fixed dose of GBM6-AD vaccine, imiquimod, and a single dose of radiation for patients with recurrent High Grade Glioma (HGG) or following standard of care therapy radiation therapy for newly diagnosed Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG).

Publications & conference data

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

1. Pattern recognition receptors: function, regulation and therapeutic potential.
   Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
2. Plasmacytoid dendritic cells at the forefront of anti-cancer immunity: rewiring strategies for tumor microenvironment remodeling.
   Monti M, Ferrari G, Gazzurelli L, Bugatti M, et al · · 2024 · cited 22× · PMID 39020402 · DOI 10.1186/s13046-024-03121-9
3. Emerging and Biological Concepts in Pediatric High-Grade Gliomas.
   Yoel A, Adjumain S, Liang Y, Daniel P, et al · · 2024 · cited 9× · PMID 39273062 · DOI 10.3390/cells13171492
4. The role of brainstem biopsy and targeted therapies in pediatric diffuse midline glioma/diffuse intrinsic pontine glioma.
   Sheikh SR, Recinos VMR, Thompson EM, Mangum R, et al · · 2024 · cited 4× · PMID 39763605 · DOI 10.3389/fonc.2024.1504440
5. Advances in tumor-associated macrophage-mediated chemotherapeutic resistance in glioma.
   Liu X, Yu Q. · · 2025 · cited 3× · PMID 41081051 · DOI 10.3389/fcell.2025.1676338
6. 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
7. Trends in the immunotherapy for glioblastoma: A two-decade bibliometric analysis.
   Long Z, Yi Z, Yan W, Wang H. · · 2025 · cited 3× · PMID 39950580 · DOI 10.1080/21645515.2025.2466299
8. Adaptive immunotherapeutic paradigms in diffuse midline glioma: integrating epigenetic reprogramming, neuron-glioma interactions, and tumor microenvironment modulation.
   Liu J, Ha JH, Abikenari M, Sjoholm MA, et al · · 2025 · cited 2× · PMID 41460355 · DOI 10.1007/s11060-025-05347-9