Open Label Immunotherapy of Myoma

NCT ID: NCT03550703

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-12-31

Brief Summary

Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

Detailed Description

Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.

Conditions

Myoma;Uterus; Fibroid Uterus; Leiomyoma; Fibroma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm receiving V3-Myoma

A single oral pill of V3-Myoma therapeutic vaccine containing pooled antigens circulating in peripheral blood and within myoma tissues

Group Type: EXPERIMENTAL

V3-Myoma

Intervention Type: BIOLOGICAL

Once daily oral pill of V3-Myoma

Interventions

V3-Myoma

Once daily oral pill of V3-Myoma

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -

Exclusion Criteria

other gynecological diseases not related to myoma hysterectomy

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Immunitor LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldar Bourinbaiar, PhD, MD/PhD

Role: STUDY_CHAIR

Immunitor LLC

Locations

Immunitor LLC

Ulaanbaatar, , Mongolia

Site Status: RECRUITING

Countries

Mongolia

Central Contacts

Galyna Kutsyna, MD, MD/PhD

Role: CONTACT

kutsynagalyna@yahoo.com

+97695130306

Marina Tarakanovskaya, MD

Role: CONTACT

info@immunitor.com

+97695130306

Facility Contacts

Aldar Bourinbaiar, MD

Role: primary

aldar@immunitor.com

97695130306

Marina Tarakanovskaya, MD

Role: backup

marinatarakanovskaya@yahoo.com

Other Identifiers

Myoma01

Identifier Type: -

Identifier Source: org_study_id