Phase 1 Study of CD200AR-L with GBM6-AD Vaccine, Imiquimod, and Radiation for Treating Recurrent High-Grade Glioma and Newly Diagnosed Diffuse Midline Glioma in Children and Young Adults

What this Trial Is About

Researchers are studying a new treatment approach for children and young adults with malignant glioma, including recurrent High Grade Glioma HGG and newly diagnosed Diffuse Midline GliomaDiffuse Intrinsic Pontine Glioma DIPGDMG. This Phase I trial aims to find the maximum tolerated dose of an experimental medicine called CD200AR-L when combined with the GBM6-AD vaccine, imiquimod cream, and a single dose of radiation. The study addresses how CD200AR-L may activate the immune system to overcome immune suppression caused by the tumor. The treatment involves up to three dose levels of CD200AR-L administered with a fixed dose of GBM6-AD vaccine and topical imiquimod cream applied to the supraclavicular area. Patients receive two consecutive days of injections weekly for three weeks, then less frequently over two years. On day 15, a single dose of 300 cGy radiation is given to help sensitize the tumor to immune attack. The study starts treatment about two weeks after standard radiation therapy for newly diagnosed patients or at recurrence for recurrent HGG patients. Participants will have regular MRI scans to monitor tumor status, blood tests for immune system evaluation, and pediatric functional assessments. Treatment continues for up to two years unless the tumor progresses, unacceptable side effects occur, or the participant chooses to leave. Safety and side effects are closely monitored, and patients may continue therapy beyond two years if it is well tolerated and effective. The study also collects blood samples for immune analysis and tracks several outcomes including time to progression and overall survival.

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