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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
OX2 Therapeutics
Study ID
NCT06305910
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Recurrent High Grade Glioma

Eligibility Criteria

Sex
ALL
Age
2 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment with CD200AR-L — DRUG
    Treatment with CD200AR-L (up to 3 dose levels of CD200AR-L with a Dose Level -1 in the event of toxicity) with fixed doses of GBM6-AD vaccine. Each patient will also be given topical imiquimod and a single dose of 300cGy re-irradiation.

Study Details

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).

Key Dates

Start date
Mar 15, 2024
Status verified
Mar 2024
Primary completion
Sep 15, 2025
Completion
Jan 15, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CD200AR-L
    Up to 3 dose levels (2.0, 3.75, and 5.0 micrograms/kg/dose) of CD200AR-L will be tested with a Dose Level -1 (1.0 microgram/kg/dose) in the event of toxicity at the 2.0 micrograms/kg/dose level. This will be given with fixed doses of 1mg GBM6-AD vaccine and topical imiquimod. A single dose of 300cGy re-irradiation will be given on Day 15. Patients with DMG/DIPG must have completed standard-of-care radiation before enrolling. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort. This study will first enroll patients ≥ 12 years of age into Dose Level 1 in order to acquire safety data prior to subsequent enrollment of study subjects aged 2-11 years.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of CD200AR-L [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's MinnesotaMinneapolisMinnesota55404
Anne Bendel, MD
[email protected]
612-813-5940

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By research site
Children's Minnesota· Minneapolis, MN

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