Actively Recruiting
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
Led by OX2 Therapeutics · Updated on 2024-03-12
24
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed newly diagnosed DIPG/DMG with H3K27M alteration or recurrent High Grade Glioma
- At least 14 days and preferably within 30 days since last radiation dose
- Diagnosis of recurrent HGG confirmed by MRI
- Maximal safe tumor resection preferred if feasible
- Clinically stable on corticosteroids not exceeding dexamethasone 0.1 mg/kg/day (max 4 mg) for at least 2 weeks
- At least 28 days since last targeted therapy, immunotherapy, or investigational agent
- At least 10 days since last anti-cancer intervention (surgery/laser) and 28 days since viral therapy
- Voluntary written consent obtained from patient (≥18 years) or guardian (<18 years)
- Able to comply with follow-up visits
- Willing to provide blood samples for immune testing
- Lansky performance score ≥60 (<16 years) or Karnofsky score ≥60 (≥16 years)
- Use of effective contraception if sexually active during 2-year treatment
- Adequate bone marrow, liver, and kidney function as defined by lab values
You will not qualify if you...
- Known allergy to GBM6-AD vaccine, CD200AR-L, or imiquimod
- Unable to complete standard radiotherapy due to progression or intolerance
- Evidence of diffuse leptomeningeal disease
- History of other cancers within 5 years
- Uncontrolled infections, heart failure, unstable angina, or psychiatric/social issues limiting compliance
- Using tumor treatment field devices (e.g., Optune) at time of consent
- Uncontrolled immune system disorders or autoimmune diseases not stable for 1 year
- Conditions affecting immune function such as HIV/AIDS, hepatitis B or C, multiple sclerosis, or renal failure
- Ongoing immunosuppressive treatment except low-dose corticosteroids
- Unable to tolerate MRI or radiation therapy even with accommodations
- Known pregnancy or expected conception during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
Research Team
A
Anne Bendel, MD
CONTACT
M
Maggie Skrypek, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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