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V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer

Study Purpose

The Phase II study to determine the safety and efficacy of V-Boost in treating a type of brain cancer called Glioblastoma Multiforme (GBM). V-Boost is an immunotherapy in which the patient's immune system will be modulated to eliminate tumor cells. V-Boost is made as an oral tablet which contains specially formulated hydrolyzed GBM antigens along with alloantigens. Patients are either newly diagnosed or with recurrent form of GBM who may have been subjected to surgery and/or chemo- or radiation therapy that ended up unsuccessful. The goal is to eradicate GBM tumor cells through daily oral administration of one pill of V-Boost immunotherapeutic vaccine, which so far has not shown any adverse reaction.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 5 Years - 99 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Confirmed diagnosis of GBM.
  • - ≥ 5 years of age.
  • - Consent from parents or legal guardian if under-aged.

Exclusion Criteria:

  • - Severe pulmonary, cardiac or other systemic disease.
  • - Presence of an acute infection requiring active treatment with antibiotics/antivirals.
- Receiving corticosteroids (e.g., dexamethasone) during study duration

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03916757
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Immunitor LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Aldar Bourinbayar, MD/PhD
Principal Investigator Affiliation Immunitor LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Mongolia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme, Glioma of Brain
Study Website: View Trial Website
Additional Details

The proposed Phase II trial is an-open label study of the safety and efficacy of V-Boost in newly diagnosed or treatment-refractory patients with glioblastoma multiforme (GBM) following unsuccesfull resection and/or chemoradiation. The Phase I clinical tria,l carried out in a small, open-label study, demonstrated safety and promising efficacy. The purpose of this study is to gain additional information from a larger clinical trial aimed to recruit at least 20 patients with GBM. Patients may be newly diagnosed with GBM or are those who have been subjected to resection and/or chemotherapy or radiation, but without success. Patients need to have imaging records and health assessment prior to study enrollment. Those on chemotherapy or radiation can be in washout period or may receive immunotherapy concurrently. Patients will be administered daily dose of V-Boost oral tablet for at least one month and additional dosing can be envisaged depending on outcome of first month. The primary objective is to evaluate the effect on tumor size and progression free survival (PFS) in comparison to patients on standard of care.

Arms & Interventions

Arms

Experimental: V-Boost recipients

In this open label study all eligible participants will receive daily tablet of V-Boost

Interventions

Biological: - V-Boost

Open label setting

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Immunitor LLC, Ulaanbaatar, Mongolia

Status

Recruiting

Address

Immunitor LLC

Ulaanbaatar, ,

Site Contact

Aldar Bourinbaiar, MD

aldar@immunitor.com

97695130306

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