drugset / Trial / NCT06305910
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
NaSequentialOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2024-03-15
- Primary completion
- 2025-09-15
- Completion
- 2027-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD200AR-L | Unknown | 1 ug/kg | Other |
| Subject | CD200AR-L | Unknown | 2 ug/kg | Other |
| Subject | CD200AR-L | Unknown | 3.75 ug/kg | Other |
| Subject | CD200AR-L | Unknown | 5 ug/kg | Other |
| Background | Imiquimod | Other / unclassified | 1 mg | Other |
| Background | Imiquimod | Other / unclassified | — | Topical |