CAR-T CELL THERAPY

WHAT IS CAR-T CELL THERAPY?
Cancerous cells accumulate certain genetic changes, divide and grow uncontrollably, leading to the development of cancer. They produce specific receptors on their surface that allow them to evade the action of lymphocytes. This results in the immune system being unable to detect and eliminate abnormal cancer cells. Immunotherapy aims to enhance the body’s ability to recognize and attack cancer cells through the immune system.
CAR-T cell therapy is a new type of immunotherapy in which specially modified T cells are used to directly and specifically target cancerous B lymphocytes, which are the basis of non-Hodgkin’s B-cell lymphomas (such as follicular lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, and small lymphocytic lymphoma). The reprogrammed T cells strengthen the immune system to attack and kill the lymphoma cells.

Samara State Medical University received a license from Roszdravnadzor for the production of adaptive immunotherapy products, including personalized CAR-T cells. This is an important step towards creating a full-cycle development and production process for modern cellular products in Russia for the treatment of oncohematological patients who have exhausted standard therapy options.

Indications for use of an individual biomedical cell product: treatment of adult patients with non-Hodgkin’s B-cell CD-19 lymphomas after two or more cycles of systemic therapy.

Contraindications to the use of an individual biomedical cellular product:

• hypersensitivity to the patient’s modified T-lymphocytes with a chimeric antigen receptor to CD19: «anti-CD19 CAR-T human cells (CD3+/anti-CD19 CAR+)» or to any of the excipients in the used product;
• pregnancy and lactation period;
• severe chronic graft-versus-host disease requiring systemic corticosteroid therapy;
• sepsis or another severe, uncontrollable infection.

STAGES AND PHASES OF CAR-T CELL THERAPY

CAR-T cells are made individually for each patient. While CAR-T cells are being produced, the patient can receive other types of treatment to keep the disease under control.
Step 1: Cell apheresis. A fraction of the patient’s own T cells is collected from the blood using a procedure called apheresis. The patient’s T cells are sent to a laboratory for production.
Stage 2: Modification of T-lymphocytes. T-cells are modified to detect and destroy cancer cells. T-lymphocytes now carry special structures called chimeric antigen receptors (CARs) on their surface.
CARs are proteins designed to attach to specific targets on cancer cells. In case of lymphoproliferative diseases, the target is the CD19 receptor, which is found on the surface of normal and tumorous B-lymphocytes.
Stage 3. Replication of CAR-T lymphocytes. In a specialized production laboratory, the patient’s CAR T cells are multiplied until they reach millions of units and are then frozen. This process can take several days to weeks.
Stage 4. Chemotherapy treatment (lymphodepletion). In order to reduce the number of normal T cells in the body and create conditions for the proliferation of CAR-T cells after administration, the patient receives chemotherapy treatment (lymphodepletion) during the preparatory stage. This typically involves chemotherapy with fludarabine and cyclophosphamide.

Step 5. CAR T-lymphocyte transfusion. The patient’s CAR-T cells are thawed and then returned to the patient’s bloodstream, similar to the transfusion of blood components or stem cells.
When CAR-T cells bind to their target receptor, they proliferate and destroy the target cells, which in this case are B-cell lymphoma and normal B-lymphocytes. CAR-T cells continue to circulate in the bloodstream to attack any recurrence of the lymphoproliferative disease.
During and after treatment, the patient will be closely monitored by the highly qualified medical staff of the Clinics. Patients receiving CAR T-cell therapy have a recovery period of approximately 2-3 months. During this period, patients will be evaluated for the development of side effects and response to treatment.

HOW TO ACCESS CAR-T CELL THERAPY AT SAMSMU CLINICS

The initial request for CAR-T cell treatment must be sent to the email address car-t@samsmu.ru with an attached copy of the hospital reference (PDF or GPG file, for foreign citizens, the reference must be in English with a Russian translation if possible). The reference must contain a list of the required test results (download the document).
A preliminary medical commission is held within 3 days of receiving the reference. If the commission makes a positive decision on the possibility of CAR-T therapy, the nearest possible date for the initial hospitalization is determined.

You must bring with you:

• original reference,
• biopsy material,
• discs with CT and PET/CT results.

As part of the initial hospitalization at the SamSMU Clinics (3 days), the patient will undergo additional tests necessary for the medical commission to make a final decision on CAR-T treatment.
The duration of hospitalization for CAR-T cell therapy in cases of lymphoproliferative diseases is up to 45 days. In some cases, a longer treatment course may be required, and the cost will be calculated based on the number of additional days.
Informed Consent (download document)

CAR-T CELL THERAPY AT SAMSMU CLINICS FOR NON-RESIDENT AND FOREIGN PATIENTS

We are aware of the severity of the condition of patients who are being admitted for CAR-T cell therapy, and we strive to ensure that the treatment is as comfortable as possible for both the patient and the accompanying persons.
Each patient is accompanied by a personal manager throughout the entire treatment process, from the initial consultation to discharge. Our manager will provide personalized assistance in resolving any issues related to travel to Samara and back, documentation, accommodation, and more.

CAR-T CELL TREATMENT COSTS

*For foreign citizens, the cost of CAR-T cell therapy for lymphoproliferative diseases (up to 45 days) will be 11,800.00 RUB.
Personal manager support is free of charge.

LEGAL BASIS

Federal Law No. 180-FZ of 23 June 2016 «On Biomedical Cell Products»
Federal Law No. 466 of July 28, 2023 «On Biomedical Cell Products»
Government Decree No. 384 dated March 28, 2024 «On Approval of the Rules for the Circulation of Biomedical Cellular Products Intended for Individual Medical Assignments …
Government Decree No. 385 dated March 28, 2024 «On Approval of the Rules for Granting, Confirming, and Revoking a Permit for the Production and Use of BMCP…»
Extract from the register of permits for the production and use of biomedical
cellular products intended for the execution of an individual
medical prescription for a biomedical cellular product,
specifically produced for an individual patient directly in
the medical organization where such a biomedical
cellular product is used as of May 19, 2026.

You can book an appointment with t hematologist by phoning: +7 (846) 374-91-00 or through you Personal account.