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New treatment option for Diffuse Midline Glioma, H3 K27M-Mutant
Official title CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults
ClinicalTrials.gov ID: NCT06305910
What this study is testing
What is Treatment with CD200AR-L?
Treatment with CD200AR-L is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for diffuse midline glioma, h3 k27m-mutant.
Also referred to as Imiquimod, GBM6-AD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 25
You may be able to join if
- Histologically confirmed newly diagnosed DIPG/DMG with documented H3K27M alteration (based on IHC or DNA sequencing performed in a CLIA-certified...
- Diagnosis of recurrent HGG based on MRI findings. Recurrent HGG must have received standard of care radiation at diagnosis. Prior biopsy material...
- 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...
- Prior therapy wash-out is required
You likely can't join if
- 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...
- Concurrent use of tumor treatment field devices (e.g., Optune) - permitted until the time of consent.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.