24 Participants Needed

CD200AR-L + Vaccine for Brain Tumors

MS
AB
Overseen ByAnne Bendel, MD
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for brain tumors in children and young adults. The main goal is to determine the safest dose of CD200AR-L, an experimental drug, when used with a vaccine and other treatments to combat aggressive brain tumors like High Grade Glioma and certain newly diagnosed tumors post-radiation. It targets individuals with recurrent High Grade Glioma or specific newly diagnosed brain tumors who have completed some standard treatments. Participants must be able to attend follow-up visits and maintain a stable health condition with controlled symptoms. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 28 days since the last dose of any targeted therapy, immunotherapy, or investigational agents, and at least 10 days since any anti-cancer intervention. If you are on these types of treatments, you will need to stop them before joining the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that CD200AR-L remains in the early testing stages to ensure safety. The primary goal is to determine the safe dosage for patients. As this is an early phase trial, limited data from human participants exists. Therefore, researchers are carefully testing the treatment to assess tolerance and identify any potential side effects.

Before human testing, scientists conducted preclinical studies and found that CD200AR-L might enhance the immune system's ability to fight tumors. However, these studies do not always predict how a treatment will perform in humans. This trial is crucial for gathering real safety data in humans.

Prospective participants should know that researchers are still closely monitoring and studying the treatment's safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain tumors, which typically involve surgery, radiation, and chemotherapy, CD200AR-L offers a novel approach. It works by using a combination of a targeted peptide and a vaccine to potentially enhance the immune system's response against tumor cells. Researchers are excited because this method could improve how the body identifies and attacks cancer, possibly leading to better outcomes with fewer side effects. Additionally, the treatment includes a strategic re-irradiation step and uses topical imiquimod to further stimulate immune activity, which is a fresh, multi-faceted approach not commonly seen in current therapies.

What evidence suggests that CD200AR-L + Vaccine might be an effective treatment for brain tumors?

In this trial, participants will receive a combination of CD200AR-L with the GBM6-AD vaccine and imiquimod, which may offer a promising treatment for aggressive brain tumors in children and young adults. CD200AR-L enhances the immune system's ability to fight the tumor. Early studies with similar treatments have shown they can slow tumor growth. The GBM6-AD vaccine aids the immune system in recognizing and attacking the tumor by targeting specific markers on the tumor cells. Imiquimod, a cream, boosts the immune response at the tumor site. Together, these treatments aim to strengthen the body's natural defenses against cancer.12346

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I finished my last radiation dose between 14 and 30 days ago.
Prior therapy wash-out required
Able to comply with follow-up visit schedule
See 8 more

Exclusion Criteria

I have had cancer within the last 5 years.
Known pregnancy or anticipated conception during study period
I am allergic to certain cancer vaccines or medications.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CD200AR-L, GBM6-AD vaccine, and imiquimod, with a single dose of radiation on day 15. Treatment includes weekly injections for the first 3 weeks, then every 4 weeks starting at week 7 for 8 weeks, and every 8 weeks starting at week 19 for 2 years.

24 months
Weekly visits for the first 3 weeks, then every 4 weeks, then every 8 weeks

Radiation

A single dose of 300 cGy radiation is administered on day 15 to sensitize the tumor to immune attack.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRIs, blood work, and performance assessments.

24 months

Open-label extension (optional)

Participants may opt into continuation of treatment beyond 2 years if they are tolerating the treatment and their tumor is controlled.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • CD200AR-L
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CD200AR-LExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

OX2 Therapeutics

Lead Sponsor

Trials
2
Recruited
50+

Published Research Related to This Trial

A study of 159 patients with grade II/III gliomas revealed significant over-expression of specific tumor-associated antigens (BCAN, CSPG4, IGF2BP3, PTPRZ1, and TNC) at both mRNA and protein levels, indicating their potential as targets for immunotherapy.
In a smaller group of 27 patients, spontaneous T cell responses to the IMA950 antigens were detected in all grade II patients and 71% of grade III patients, suggesting that these antigens are relevant for effective tumor targeting and could enhance the efficacy of immunotherapy when combined with other peptides.
Antigenic expression and spontaneous immune responses support the use of a selected peptide set from the IMA950 glioblastoma vaccine for immunotherapy of grade II and III glioma.Dutoit, V., Migliorini, D., Ranzanici, G., et al.[2021]
Vaccination strategies targeting cancer-associated antigens have shown promise in preclinical brain tumor models, demonstrating the immune system's ability to safely eliminate established tumors in the central nervous system.
Early phase clinical trials, particularly in glioblastoma patients, have confirmed the safety and immunogenicity of these vaccines, with initial results suggesting potential clinical benefits, although further studies are needed to establish definitive outcomes.
Vaccination strategies for neuro-oncology.Sampson, JH., Mitchell, DA.[2018]
The study introduces a new peptide ligand, CD200AR-L, which targets the CD200 immune-checkpoint receptor, showing potential to enhance anti-glioma responses by activating the DAP10 signaling pathway, crucial for tumor control.
Combining CD200AR-L with immune-stimulatory gene therapy in an intracranial glioblastoma model significantly increased median survival and resulted in long-term survivors, indicating a promising new approach for glioblastoma treatment currently under investigation in a phase I trial.
CD200 Immune-Checkpoint Peptide Elicits an Anti-glioma Response Through the DAP10 Signaling Pathway.Ampudia-Mesias, E., Puerta-Martinez, F., Bridges, M., et al.[2023]

Citations

NCT06305910 | CD200AR-L and Allogeneic Tumor Lysate ...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 ...
Novel combined vaccine therapy for malignant gliomas in ...A novel combined vaccine therapy for newly diagnosed diffuse midline glioma (DMG) and recurrent high-grade glioma (HGG) in pediatric and young adult patients.
CD200AR-L and Allogeneic Tumor Lysate Vaccine ...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, ...
CD200AR-L and Allogeneic Tumor Lysate Vaccine ...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, ...
CD200AR-L and Allogeneic Tumor Lysate Vaccine ...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 ...
CD200AR-L: mechanism of action and preclinical ...We suggest that the CD200 protein is a mechanism for the tumor to evade the immune system. In recent experiments, we discovered that knocking ...
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