Autologous Antigen-activated Dendritic Cells in the Treatment of Patients With Breast Cancer (BC-LDC)

Research Institute of Fundamental and Clinical Immunology

Status and phase: Unknown; Early Phase 1

Conditions: Breast Cancer

Treatments: Biological: Immunotherapy based on dendritic cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03113019

Breast Cancer Lyzate DC

Details and patient eligibility

About

The purpose of this work: to assess the tolerability and effectiveness of the autogemotherapy method on the basis of autologous antigen-activated dendritic cells in the treatment of patients with breast cancer.

This technology is intended for complex treatment of patients with breast cancer and is aimed at preventing the occurrence and treatment of secondary foci. The need for this technology is justified by the widespread occurrence of breast cancer among women, a decrease in the average age at onset of the disease and a young age, and the chemoresistantness of locally advanced forms of cancer.

Full description

Currently, technologies are being developed to improve the clinical outcomes of patients with complex treatment of breast cancer. Many patients are immunosuppressed after surgical, radiation and chemotherapeutic treatment, which leads to dysfunction of T cells, resulting in tumor cells avoiding immune surveillance. Restoration of antitumor immunity during immunotherapy is one of the modern approaches in the treatment of breast cancer, which contributes to the formation of an effective specific immune response, the destruction of tumor cells while minimizing toxicity. Dendritic cells (DC) and the lymphocytes induced by them are one of the most effective methods for the destruction of residual cancer cells, which are the leading cause of relapse and metastasis.

Enrollment: 26 patients

Sex: Female

Ages: 28 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. For the first time established morphologically confirmed diagnosis of breast cancer
2. patients with II A, II B, IIIA, III B stages of breast cancer;
3. Patients with progressive or primary IV stage of breast cancer with cytologically confirmed and accessible soft tissue metastases;
4. Patients with HER-2 / neu 3 + positive and patients with triple negative breast cancer of the I-II stage (biologically unfavorable forms of breast cancer more prone to recurrence and metastasis).
5. Absence of severe somatic pathology in which medical intervention (at the stage of obtaining biological material or the stage of immunotherapy) will only worsen the patient's condition,
6. The patient's desire.

Exclusion criteria

1. Pregnancy at any time,
2. Impossibility of correction of therapy of concomitant diseases, if the taken preparations are proved to influence the immune status,
3. Rapid progression of the underlying disease, in which the use of immunotherapy is deontologically unjustified,
4. Individual intolerance to the components of the vaccine and / or the development of severe side effects on any of the components,
5. Refusal of the patient to participate in the study in oral or written form.
6. Patient involvement in any other clinical study (including those that the patient has not been informed by the direct oncologist who has been treated, but which has become known already after the beginning of any stage of the study).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Immunotherapy based on dendritic cells

Experimental group

Description:

Intravenous administration dendritic cell and activated mononuclear cells at least 3 times 20-30 million cells / injection

Treatment:

Biological: Immunotherapy based on dendritic cells