An effective way to combat tumor cells remaining after radical treatment and posing a risk of disease recurrence is to activate the patient’s own immune system.

Modern methods of personalized CIT involve the use of BMCPs based on the patient’s own MDCs and/or CIKCs, programmed to attack and destroy cancer cells.

MDCs are specialized and the most powerful antigen-presenting cells of the human immune system, performing the primary function of generating antitumor immunity.

Using BMCPs based on MDCs, it is possible to initiate a targeted immune response against a specific tumor. Such BMCPs are often referred to as a DC vaccine.

CIT using BMCPs based on CIKCs is based on the ability of the patient’s own cytotoxic T lymphocytes to attack and destroy foreign cells, including cancer cells.

Furthermore, the administration of in vitro-activated CIKCs triggers a series of intercellular interactions in the patient’s body, leading to the activation of other immune cells and enhanced antitumor immunity overall.

CIT is indicated for patients with chemoresistant solid tumors (stomach, pancreatic, breast, bladder, prostate, uterine, ovarian, and lung cancer, among others) after radical surgery and standard postoperative treatment (chemoradiotherapy).

For certain indications, combination immunotherapy may be used, with sequential use of MDC-based BMCPs and CIKCs.

This type of CIT is effective, for example, in recurrent and metastatic kidney cancer and primary and recurrent non-muscle-invasive bladder cancer.

However, CIT is not a «panacea» and does not guarantee a cure for a cancer patient.

Indications and contraindications for its use are determined by an oncologist. In addition, CIT does not replace or cancel (!) basic therapy for oncological diseases, including chemotherapy, radiation therapy, etc.

Treatment Scheme

Peripheral venous blood serves as the biomaterial for the production of BMCPs.

50-100 ml of blood is sufficient to obtain one therapeutic dose of MDCs or CIKCs.

Monocytes isolated from the blood are «loaded» with tumor antigens outside the body (in vitro), allowing the production of mature MDCs capable of activating the immune response.

Individual native tumor antigens (tumor lysates) and synthetic standardized TAAs are used as antigen material to create BMCPs based on MDCs.

To produce CIKC-based BMCPs, killer T lymphocytes are isolated from venous blood and cultured (expanded) in the laboratory to the required number, enhancing the cells’ antitumor activity with specific cytokines.

The quantity of MDCs and CIKCs obtained is determined by the initial number of native monocytes in the patient’s blood and is reflected in the «BMCP Analytical Passport.»

A low monocyte count in the patient’s blood at the time of biopsy will prevent the adequate amount of MDC and CIKC from being obtained, so low monocyte and hemoglobin levels are grounds for refusing blood sampling.

BMCP administration is performed in a procedure room: BMCP containing MDC (12 ml) is administered subcutaneously in the shoulder, while BMCP containing CIKC is administered intravenously.

A course of CIT includes 5 doses of BMCP containing MDC.

During one course, blood is drawn 5 times and BMCP is administered 5 times, with 6-day intervals between each blood draw and administration, and 8 days between each administration and the next blood draw.

Thus, the patient undergoes 10 visits over 2.5 months.

A course of CIT using CIKC involves administering 3-5 doses of BMCP at intervals of 1-1.5 months.

Effectiveness

CIT is considered an additional treatment method, not a «panacea,» and does not guarantee the cure of an oncological patient.

But it highly likely stabilizes the oncological process, increases the relapse-free period, and overall life expectancy, as well as regulates the timing of subsequent chemotherapy lines.

The clinical effect of one CIT course (5 doses) is manifested by the stabilization of the tumor process (in 40-50% of cases), sometimes with partial or complete regression (5-15%), and can last on average from 3 months to a year or more.

There is a risk of low MDC efficacy when standardized synthetic TAAs are used for BMCP production, the expression of which by the tumor is not confirmed by immunohistochemical analysis.

The insufficient therapeutic effect of CIKC is often associated with tumor resistance to the cytotoxic action of T lymphocytes.

In some cases, the combination of CIKC and MDC helps overcome tumor resistance to the immune response and reduce the potential for recurrence.

Criteria for CIT effectiveness are:

• absence of disease progression according to ultrasound and CT results;
• reduction of T-regulatory cells in peripheral blood;
• reduction of CTC content in peripheral blood.

Treatment can be administered at any time after radical or palliative surgery, as well as in combination with chemotherapy and other types of immunotherapy.

The maximum clinical effect of CIT can be expected when it is administered regularly in the adjuvant setting after removal of the primary tumor (postoperatively) to prevent tumor recurrence and eliminate invisible micrometastases.

In cases of widespread tumor progression and severe metastatic disease, CIT is not an appropriate treatment option and does not offer the patient significant efficacy.

Safety and complications

There is a possibility of low efficiency of DC when using standardized synthetic TAA for their production, the expression of which by the tumor is not confirmed by IHC data.

Autoimmune and chronic infectious diseases significantly reduce the efficiency of cellular immunotherapy.

One cannot expect to obtain a good clinical result if the patient has chronic diseases in the acute stage, alcohol and drug addiction.

To date, the excellent tolerability and absolute safety of CIT have been proven many times.

The use of autologous MDC and CIKC does not cause allergic, toxic reactions, does not suppress the immune system and does not stimulate tumor growth.

Direct administration of BMCP may be accompanied by a short-term (1-2 days) increase in body temperature to 38 ° C, redness and swelling of the injection site, which do not require medical care and pass on their own.