Actively Recruiting
Phase I Trial of CD200 Activation Receptor Ligand and Tumor Lysate Vaccine with Radiation for Recurrent High-Grade Glioma and Newly Diagnosed Diffuse Midline Glioma in Children and Young Adults
Led by OX2 Therapeutics · Updated on 2024-03-12
24
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
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 Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG). 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.
CONDITIONS
Brief 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 documented H3K27M alteration or recurrent High Grade Glioma
- Minimum 14 days and preferably within 30 days from last radiation dose for newly diagnosed patients
- Diagnosis of recurrent HGG based on MRI with prior standard radiation at diagnosis
- Maximal safe tumor resection preferred if feasible before enrollment
- 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 dose of targeted therapy, immunotherapy, or investigational agents
- At least 10 days since anti-cancer interventions like surgery or laser ablation; 28 days since viral therapy
- Voluntary written consent obtained (patient if ≥18 years, guardian if <18 years)
- Able to comply with follow-up visit schedule
- Willing to allow pre-treatment blood collection for immune studies
- Lansky or Karnofsky performance score ≥60 depending on age
- Agree to use highly effective contraception if of child-bearing potential during 2-year treatment
- Adequate bone marrow, liver, and kidney function as specified
You will not qualify if you...
- Known sensitivity to GBM6-AD vaccine, CD200AR-L, or imiquimod
- Unable to complete standard radiation due to progression or intolerance
- Radiographic evidence of diffuse leptomeningeal disease
- History of malignancy within 5 years
- Uncontrolled illnesses including active infections, heart failure, unstable angina, psychiatric or social issues limiting compliance
- Concurrent use of tumor treatment field devices like Optune until consent
- Uncontrolled immune system abnormalities including autoimmune diseases or immunodeficiency
- Conditions altering immune function such as HIV/AIDS, hepatitis B or C, multiple sclerosis, renal failure
- Ongoing immunosuppressive drugs except low dose corticosteroids as allowed
- Unable to tolerate MRI or radiation even with accommodations
- Known pregnancy or planned conception during study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years unless disease progression, unacceptable toxicity, or withdrawal occurs
Participants receive CD200AR-L, GBM6-AD vaccine, and imiquimod cream, along with a single dose of radiation on Day 15 to help sensitize the tumor to immune attack. Vaccine treatments are given on two consecutive outpatient visits each week for the first 3 weeks, then every 4 weeks for the next 8 weeks, and then every 8 weeks for up to 2 years.
Two-day injection series weekly for 3 weeks, then every 4 weeks for 8 weeks, then every 8 weeks for up to 2 years
Trial Site Locations
Total: 1 location
1
Children's Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
Research Team
A
Anne Bendel, MD
M
Maggie Skrypek, MD
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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