CD200AR-L and Vaccine Immunotherapy for Pediatric Brain Tumors
This study is testing a new treatment for children and young adults (ages 2-25) with recurrent High-Grade Glioma (HGG) or newly diagnosed Diffuse Midline Glioma (DMG/DIPG) with a specific H3 K27M gene change. It combines a drug called CD200AR-L with a vaccine (GBM6-AD), a skin cream (imiquimod), and a single dose of radiation. The goal is to find the highest safe dose of CD200AR-L when given with these other treatments. Researchers believe CD200AR-L may help activate the body's immune system to fight the tumor, especially since previous studies showed the vaccine's effectiveness was limited by the tumor's ability to suppress immune cells. This is a single-center study with a planned enrollment of 24 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a single-center study with a planned enrollment of 24 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose of CD200AR-L will be measured at 24 months.
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NCT06305910
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
Recruiting
PHASE1Ages 2–25InterventionalTreatmentOX2 Therapeutics
~24 participants
Updated 2024-03-12 on ClinicalTrials.gov
What's tested:Treatment with CD200AR-L
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD) of CD200AR-L
Measured over 24 months
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Histologically confirmed newly diagnosed DIPG/DMG with documented H3K27M alteration (based on IHC or DNA sequencing performed in a CLIA-certified laboratory) or recurrent HGG. Patients cannot enroll until they are a minimum of 14 days and preferably within 30 days from the last dose of radiation.
Diagnosis of recurrent HGG based on MRI findings. Recurrent HGG must have received standard of care radiation at diagnosis. Prior biopsy material will be required to confirm diagnosis of HGG; however, biopsy of the recurrent/progressive lesion will not be required for study enrollment.
Maximal safe resection is preferred prior to clinical trial enrollment if indicated and feasible.
Clinically stable on a dose of corticosteroids not to exceed an equivalent of dexamethasone 0.1 mg/kg/day (maximum 4 mg) for at least 2 weeks prior to study enrollment.
Prior therapy wash-out is required
Minimum of 28 days since last dose of any targeted therapy (including bevacizumab), immunotherapy, investigational agents.
Minimum of 10 days since any anti-cancer intervention: cytoreductive surgery/laser ablation and a minimum of 28 days since any viral therapy
Voluntary written consent obtained by patient if ≥18 years of age or a parent or guardian if \<18 years of age before the performance of any study-related procedure not part of standard medical care
Able to comply with follow-up visit schedule (i.e., return to clinic for follow-up visits).
Willing to allow for collection of pre-treatment research related blood collection \[1-5 mL red top tube and 2-10 mL green top tubes (or to a max of 2 ml/kg of body weight)\] for immune characterization. If a patient does not subsequently enroll in the study, the samples will be destroyed according to institutional protocol.
Lansky play performance score ≥60 (\<16 years) or Karnofsky (≥16 years) performance score of ≥60
Sexually active persons of child-bearing potential or with partners of childbearing potential must agree to use a highly effective form of contraception during the 2-year treatment period. Urine pregnancy tests will be obtained at defined time points during protocol therapy.
Adequate bone marrow reserve: Absolute neutrophil (segmented and bands) count (ANC) ≥1.0 x 10E9/L, platelets ≥75 x 10E9/L; Hemoglobin ≥8 g/dL
Hepatic: Bilirubin ≤1.3 mg/dL and SGPT (ALT) ≤2.5 x upper limit of normal (ULN) for age
Renal: Normal serum creatinine for age or creatinine clearance \>60 ml/min/1.73 mE2
Exclusion
Known sensitivity to the GBM6-AD tumor lysate vaccine, CD200AR-L, or imiquimod.
Unable to complete a standard upfront course of radiotherapy due to disease progression or intolerance of therapy.
Radiographic evidence of diffuse leptomeningeal disease.
Prior history of malignancy within 5 years of enrollment.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Concurrent use of tumor treatment field devices (e.g., Optune) - permitted until the time of consent.
History of any laboratory findings consistent with any uncontrolled immune system abnormalities such as hyper-immunity (e.g., autoimmune diseases, thyroid dysfunction, lupus, scleroderma, etc.) and hypo-immunity \[e.g., myelodysplastic disorders, marrow failures, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), transplant immune-suppression, etc.\]. Any known autoimmune disease must be clinically silent and without associated laboratory abnormalities for at least 1 year in the absence of any disease directed therapy or systemic steroids.
Any conditions that could potentially alter immune function (e.g., HIV/AIDS, hepatitis B, untreated hepatitis C, multiple sclerosis, renal failure).
Receiving ongoing treatment with any immunosuppressive drug for any reason, excluding those patients requiring a low dose of corticosteroids equivalent to dexamethasone 0.1 mg/kg/day (maximum 4 mg) or less for treatment of tumor-related edema.
Not able to tolerate an MRI or radiation therapy even with reasonable accommodations or sedation.
Known pregnancy or anticipated conception during the 1-year study period
What this trial measures
- Maximum Tolerated Dose (MTD) of CD200AR-L24 months
Maximum tolerated dose (MTD) of CD200AR-L when administered with imiquimod and GBM6-AD vaccine to treat High-Grade Glioma (HGG) and Newly Diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DMG/DIPG) in children and young adults.