← Back to Search

Cancer Vaccine

CD200AR-L for Brain Tumor

Phase 1

Recruiting

Research Sponsored by OX2 Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for brain tumors in children and young adults. They are using a combination of drugs including CD200AR-L, imiquimod, and a vaccine called GBM

Who is the study for?

This trial is for children and young adults with malignant glioma, specifically those with recurrent High Grade Glioma (HGG) or newly diagnosed Diffuse Midline Glioma/Diffuse Intrinsic Pontine Glioma (DIPG/DMG). Participants must have completed standard radiation therapy if they are newly diagnosed.Check my eligibility

What is being tested?

The study tests a new treatment called CD200AR-L combined with imiquimod and GBM6-AD vaccine. It aims to find the highest dose of CD200AR-L that's safe when given alongside these treatments and a single dose of radiation in patients with certain brain tumors.See study design

What are the potential side effects?

Potential side effects aren't specified here, but generally, immunotherapy can cause reactions at the injection site, flu-like symptoms, fatigue, fever, and sometimes more serious immune-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of CD200AR-L

Secondary outcome measures

Incidence of serious adverse events (SAEs)

Overall survival (OS) by 24 months

Progression free survival (PFS) by 24 months

+1 more

Side effects data

From 2007 Phase 4 trial • 551 Patients • NCT00116649

30%

Actinic Keratosis

23%

Application site pruritus

15%

Basal cell carcinoma

15%

Squamous cell carcinoma

11%

Skin lesion

Application site irritation

Seborrhoeic Keratosis

Skin Papilloma

Fatigue

Application site pain

Upper respiratory tract infection

Myocardial infarction

Coronary artery disease

100%

80%

60%

40%

20%

Study treatment Arm

Aldara (Imiquimod) Cream

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD200AR-LExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

OX2 TherapeuticsLead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for individuals to enroll in this clinical trial?

"As per clinicaltrials.gov, this investigation is actively enrolling participants. The trial was first listed on March 15th, 2024 and last modified on March 5th of the same year."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Yes, the details available on clinicaltrials.gov indicate that this research project is actively looking for suitable candidates. The study was first listed on March 15, 2024, and its most recent update was made on March 5, 2024. Recruitment aims to enroll a total of 24 participants from a single designated site."

Answered by AI

What are the potential risks associated with CD200AR-L for individuals receiving treatment?

"The safety rating for CD200AR-L, according to our team at Power, is positioned at 1 due to being in the initial Phase 1 trial stage with scarce supporting data on both safety and efficacy."

Answered by AI

Is the medical study open to participants younger than 60 years old?

"Participants aged between 2 and 25 are eligible to enroll in this study. Notably, there are a total of 250 trials targeting individuals under 18 years old and 1096 focusing on those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG and Newly Diagnosed DMG/DIPG in Children and Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305910.

All > Paid Studies Minneapolis