Introduction

brhejo

The BRICS Health Journal

3034-47003034-4719

Sechenov University

10.47093/3034-4700.2026.3.1.64-73

brhejo-108

Research Article

Economics and Health Technology Assessment

Analysis of the CAR-T cell therapy landscape in Russia

Shchurov

Dmitry G.

Dmitry G. Shchurov, PhD, Head of the Expert and Analytical Healthcare Horizon Scanning Centre, Associate Professor of the Department of Technological Leadership, Sechenov First Moscow State Medical University (Sechenov University)

8/2, Trubetskaya str., Moscow, 119048

Mizin

Igor N.

Igor N. Mizin, Intern Researcher at the Expert and Analytical Healthcare Horizon Scanning Centre, Sechenov First Moscow State Medical University (Sechenov University)

8/2, Trubetskaya str., Moscow, 119048

Sechenov First Moscow State Medical University (Sechenov University)Russian Federation

2026

14082026

316473

2026

Shchurov D.G., Mizin I.N.

This work is licensed under a Creative Commons Attribution 4.0 License.

https://www.bricshealthjournal.com/jour/article/view/108

The objective of this study was to provide a comprehensive overview of the CAR-T (chimeric antigen receptor T-cells) therapy landscape in Russia, including the types of products used, their target antigens, indications, the role of CAR-T therapy in treatment pathways, clinical trials, marketing authorization, and production infrastructure data. A key feature of the Russian landscape is the emergence of a hybrid ecosystem in which academically developed products coexist with the first industrial CAR-T products. Monospecific constructs targeting cluster of differentiation (CD) 19 are the most common. Bispecific and polyspecific CAR-T variants are also being developed. This technology has been used for the treatment of nine lymphoproliferative diseases. In the vast majority of cases, CAR-T therapy was used as a salvage therapy in later stages of treatment. The expected number of patients in clinical trials exceeds 200. One commercial CAR-T product has been approved, and another is in the final stages of research and obtaining marketing authorization. The number of licensed organizations with CAR-T production infrastructure is growing. Currently, five organizations hold authorizations for the production and use of individual biomedical cell products, and five hold licenses for the manufacture of gene therapy biological medicinal products. Further development of this technology will depend on how successfully key challenges are addressed, including production scale-up, patient routing, payment models, and the systematic collection of real-world clinical data. For BRICS countries, the Russian experience may be considered one example of how complex and high-cost cell therapy can be introduced into a national healthcare system. International cooperation on regulatory and funding issues, as well as joint clinical trials of industrial CAR-T technologies, could accelerate the development of this field in the BRICS countries.

Russian healthcare systemcell treatmentCAR-T manufacturing sitesBRICS healthcare systemsacademic manufacturingindustrial manufacturingpersonalized medicine

Introduction

Modern gene-cell technologies allow us to create of chimeric receptors on the surface of effector cells that target specific antigens, such as tumor cell antigens. The reprogrammed T-lymphocytes are known as CAR-T (chimeric antigen receptor T-cells) [1]. A favorable benefit-to-risk ratio has ensured the expansion of their production and implementation in real clinical practice. There are different types of CAR-T cells, such as autologous (from the patient) and allogeneic (from a donor), targeting different numbers of antigens. The technology has found its greatest application in oncohematology [2]. Since the world’s first successful CAR-T therapy in 2010, there has been an exponential growth in publications on this topic1.

For BRICS countries, CAR-T therapy can be considered not only as a gene-cell therapy approach, but also as a case for studying the implementation of high-cost and technologically complex treatment in national healthcare systems. This issue is associated with several practical factors, including access to therapy, local production capacity, regulatory requirements, and treatment costs. Recent reviews describe the global development of CAR-T therapy and its clinical trials, and some papers also discuss the experience of countries with developing biomedical infrastructure, including Russia and China [3][4]. Although several publications address selected aspects of CAR-T therapy development in Russia, China, and other countries with developing biomedical infrastructure, the available literature appears to cover the Russian experience only partially. In particular, there is limited consolidated information on clinical use, patient groups, investigational and authorized products, manufacturers, regulatory sources, clinical trials, and organizations providing CAR-T therapy in Russia.

The aim of this review was to form a holistic understanding of the CAR-T landscape in Russia.

To analyze the Russian experience, the following sources were used: the eLibrary and ClinicalTrials.gov databases, state registries of medicines, drugs production licenses, clinical trial permits, the registry of permits for the use of individual biomedical cell products and the official websites of the relevant specialized federal medical organizations as of June 2026. A search of eLibrary was performed using the following search queries in Russian: “CAR-T терапия” (CAR-T therapy), “CAR-T случай” (CAR-T case), and the names of the specialized federal medical organizations. The primary criteria for publication selection – the availability of original data on the clinical use of CAR-T therapy in Russia or cases involving Russian patients treated abroad. Abstracts that did not provide data on CAR-T type, patient characteristics, or indications, as well as abstracts written by foreign authors were excluded, with the exception of Russian and Belarusian joint publications. A search of the Russian clinical trial registry was conducted using the keywords “CAR-T” and “CAR T”. ClinicalTrials.gov was searched using the keyword “CAR-T” in the intervention field with the region filter set to “Russia”.

The technology evolution: from mono-CD19 to polyspecific variants

The evolution of Russian CAR-T cells follows largely speaking the path navigated in other countries – from single autologous monospecific constructs to an increasing diversity of target antigens. A search of eLibrary yielded 26 articles and abstracts describing the Russian experience. Most studies and reports describe the use of autologous CAR-T cells [5–23], whereas only six publications describe allogeneic cells, including cells from related haploidentical donors, human leukocyte antigen (HLA)-matched siblings, and unrelated donors [20][22][24–27]. Monospecific anti-CD19 CAR-T prevail in the analyzed studies and reports [5–14][16–27], while bispecific cluster of differentiation (CD) 19/CD22 and polyspecific constructs (three or more antigens: CD19/20/22, CD19/22/ disialoganglioside [GD] 2, CD19/CD30/CD22/PSMA [prostate-specific membrane antigen], CD19/CD20/CD79b/PSMA/CD70) are presented in eight and two publications, respectively [6][7][13][15][17][18][25][26] (Figure 1). Experience with CAR-T therapy targeted at CD33 and CD123 in children with acute myeloid leukemia (AML) is also described [22]. Thus, the technology in Russia has come a long way from the days of reproducing the basic mono-CD19 design to the independent development of bispecific and polyspecific variants.

FIG. 1. Type of chimeric antigen receptor T-cells (CAR-T) in publications

Note: A – by cell source; B – by antigen specificity; CD – cluster of differentiation.

https://cdn.elpub.ru/assets/journals/brhejo/2026/1/Ur4hKCk9FHyV4VEQYEPrKJ0Jqi1aIkIGnMbEt2HQ.jpegCAR-T therapy in Russia: treatment pathways, indications, and clinical trials

In the vast majority of cases, CAR-T therapy was used as salvage therapy after previous lines of treatment in Russia failed to succeed [5–7][9–12][14–27]. The use of CAR-T in the first line of treatment was described only in the Zvonkov et al. publication: in a patient with mantle cell lymphoma [8]. Thus, in the analyzed sources, the use of CAR-T therapy as first-line treatment is described infrequently, even though this strategy might be a better treatment option. In some studies, blinatumomab therapy served as a “bridge” to CAR-T [5][11][14][20][23–25][27], and allogeneic hematopoietic stem cell transplantation as a consolidation stage [11][17][20][21][23–25][27]. These observations suggest that CAR-T therapy is often integrated into multimodal treatment strategies rather than used as a stand-alone approach.

The profile of a patient treated with CAR-T in Russia is diverse. CAR-T therapy is used for the treatment of both adults and children, and currently covers nine lymphoproliferative diseases. The most common diagnosis for the use of CAR-T therapy in Russia is B-cell acute lymphoblastic leukemia (ALL) [5][6][9][11][14][17][19–21][23][25][27]. Diffuse large B-cell lymphoma is mentioned in three academic publications [7][13][16] and in one press release2. AML, follicular lymphoma, Burkitt’s lymphoma, mantle cell lymphoma, primary central nervous system lymphoma, primary mediastinal large B-cell lymphoma, and lymphoblastic lymphoma were also described (Figure 2) [7][8][12][13][18][22][24][26].

FIG. 2. Indications for the use of chimeric antigen receptor T-cells (CAR-T) therapy in selected publications

Note: ALL – acute lymphoblastic leukemia; DLBCL – diffuse large B-cell lymphoma; MLBCL – mediastinal large B-cell lymphoma; AML – acute myeloid leukemia; CNS – central nervous system.

https://cdn.elpub.ru/assets/journals/brhejo/2026/1/erSaAK1ZB69J9zPc6wiEtJURwAjuGPjFDPmvoQ1C.jpeg

The clinical trial landscape reflects the further development of this approach. The state registry of clinical trial permits contains information on two trials of the drug with the international nonproprietary name (INN) hemagenlecleucel, which is a second-generation CAR-T specific to the B-cell CD19 antigen. The trials are being conducted by the National Medical Research Center for Hematology in a group of patients with relapsed and refractory B-cell lymphoproliferative disorders. One of the trials was completed. The second is scheduled for completion on December 31, 20263.

The international clinical trials database ClinicalTrials.gov contains information on five clinical trials using CAR-T technology in Russia. Four of them are being conducted at the National Medical Research Center for Hematology and the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology in Moscow, and only one at the Regional Hematology Center of Clinical Hospital No. 2 in Vladivostok. All four studies, conducted in Moscow, are aimed at evaluating the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia, as well as B-cell non-Hodgkin’s lymphoma. The CAR-T cells are designed using receptors for CD19 and CD19/CD22 antigens. The study in Vladivostok is being conducted to evaluate the efficacy and safety of CAR-T in patients with multiple myeloma or plasmacytoma. The target antigens used are B-cell maturation antigen (BCMA) and G-protein coupled receptor family C group 5 member D (GPRC5D)4. The total expected number of patients in the clinical trials exceeds 200.

Academic and industrial models of CAR-T therapy in Russia

The CAR-T landscape comprises two complementary components: the academic and the industrial.

Academic CAR-T represents the earliest and currently dominant segment of the CAR-T ecosystem in Russia. The majority of reported treatment cases relate to academic CAR-T, which are produced as individual biomedical cell products (iBMCP) directly at clinical centers. Manufacturing and clinical experience are concentrated in two federal centers with clearly defined specialization. The National Medical Research Center for Hematology is the leading organization in the development and clinical use of academic CAR-T for adult patients. CAR-T cells produced at the center have been reported in 11 publications [7][8][10–12][14–18][20], The Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology (Moscow) is the leading organization in the development and clinical use of academic CAR-T for the pediatric patients. T-lymphocytes produced at the center have also been reported in 11 publications [5][6][19–27]. In addition to these two leading centers, the technology has also begun to be used at the National Medical Research Radiological Center5, 6.

The academic model of in-hospital development represents an important component of the CAR-T ecosystem, as it enables rapid technological advancement. The most complex polyspecific CAR-T constructs have emerged within this academic model.

Alongside the academic model, industrial, or commercial, CAR-T represents the second and emerging segment of the CAR-T ecosystem in Russia. Only one of the identified and included scientific publications provides information on the use of the only CAR-T product currently approved in Russia with the INN tisagenlecleucel. It was first used in 2025 to treat a child with relapsed ALL at Morozov Children’s Hospital in Moscow [19]. In December 2025, information on two additional treatment cases of children with this industrial product was published on the website of Moscow Medicine7. It is worth noting that in addition to the already approved CAR-T product, a domestic commercial CAR-T product with the INN hemagenlecleucel is undergoing final-stage clinical trials. Thus, the industrial CAR-T model is also developing in Russia and in the near future will be represented by two products, one of which is domestically developed.

CAR-T infrastructure and access in Russia

The academic and industrial segments of the CAR-T ecosystem rely on manufacturing infrastructure whose development dynamics can be assessed based on the number of licenses granted to organizations. An analysis of state registries identified nine organizations with the capacity to produce academic or industrial CAR-T products (Table). Five organizations hold authorizations for the production and use of iBMCP, which are academic CAR-T products, and five hold licenses for the manufacture of gene therapy biological medicinal products (GBMP), such as industrial CAR-T products. The National Medical Research Center for Hematology is included in both lists8, 9. The coexistence of two types of regulatory authorization, iBMCP and GBMP, is an institutional feature of the hybrid model.

Table. Organizations that hold authorizations for production of individual biomedical cell products and gene therapy biological medicinal products in Russia

Note: Information is provided as of the beginning of June 2026.

Organizations authorized to produce and use of individual biomedical cell products, year of authorization	Organizations authorized to manufacture gene therapy biological medicinal products, year of authorization
Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology, 2025	The National Research Center for Epidemiology and Microbiology named after Honorary Academician N.F. Gamaleya, branch “Medgamal”, 2021
National Medical Research Radiological Center, 2025	JSC “BIOCHIMIC”, 2024
Sechenov First Moscow State Medical University (Sechenov University), 2025	JSC “BIOCAD”, 2025
National Medical Research Center for Hematology, 2026	JSC “GENERIUM”, 2025
Samara State Medical University, 2026	National Medical Research Center for Hematology, 2026

The development of this production infrastructure is closely related to the issue of patient access to CAR-T therapy and its financing. Several publications have described the experience of using CAR-T therapy in Russian patients treated abroad, primarily in China [19][28][29]. It is worth noting that seeking treatment abroad was mainly driven by the lack of availability of specific CAR-T products for certain diseases in the Russian market. Access to CAR-T therapy for patients in Russia depends on both the availability of production infrastructure and financing mechanisms. The first cases of treatment with industrial CAR-T were covered by targeted financial instruments, such as the Moscow Government Grant [19], while academic CAR-T therapy was financed by private funds. In 2026, a tariff for the use of CAR-T, amounting to 7.03 million rubles (approximately 90,000 USD), was introduced into the high-tech medical care system10. This creates a basis for the sustainable financing of this technology and provides incentives for the development of CAR-T research and production centers, as well as the wider implementation of this technology in clinical practice.

Directions of CAR-T therapy development in Russia

This review provides a holistic understanding of the CAR-T therapy landscape in Russia, including the types of products used, their target antigens, indications, the role of CAR-T in treatment pathways, clinical trials, market authorization, and production infrastructure data. The analysis addresses the following questions: what has already been established, what remains lacking, and what is needed for further scaling up of this technology.

The analysis showed that a hybrid model has already been established in Russia. On the one hand, there are strong academic centers producing iBMCP. On the other, an industrial loop focused on the manufacture of GBMP has emerged. Nowadays, nine organizations are authorized to produce CAR-T products. The two segments of the CAR-T ecosystem complement each other: the academic loop provides flexibility in development and enables an individualized approach to treatment, whereas the industrial loop supports standardization and scalability.

Despite the established framework, several systemic elements remain unresolved. The scalability of the model remains unclear, patient routing has not been formalized, and the sustainability of the payment model as patient numbers increase is still unclear. The current tariff is unable to cover treatment costs when the CAR-T product targets an antigen other than CD19. This limits the range of diseases covered with the tariff and slows the development of other variants of CAR-T technology. A national registry is also lacking, limiting the ability to assess the efficacy and safety of this technology at the national level. Therefore, several areas are priorities for the transition from an emerging to a mature ecosystem. These priorities include formalizing patient routing, extending expertise beyond Moscow, expanding good manufacturing practice (GMP) compliant manufacturing capacity, establishing a national CAR-T registry, for instance within the framework of the currently developing Federal Registry, and harmonizing academic (iBMCP) and industrial (GBMP) approaches. The coordinated development of these elements will determine whether the hybrid model can translate into a sustainable advantage or remain a collection of disparate initiatives.

This review is the first to examine the CAR-T landscape in Russia across a broad range of domains. One limitation of the study was the use of data from both full-text articles and abstracts. However, abstracts that did not provide information on CAR-T type, patient characteristics, or indications for use were excluded.

Conclusion

CAR-T is a new and rapidly developing technology in Russia, already characterized by a diversity of designs, target antigens, and indications for use. A hybrid CAR-T ecosystem is emerging in the country, in which academically developed individual products coexist with the first industrially manufactured products. The number of licensed organizations with CAR-T production infrastructure is growing. Further development of this field will depend on how successfully key challenges are addressed, including issues of scaling, patient routing, expansion of production capacity, payment models, and the systematic collection of real-world clinical data. For the BRICS countries, the Russian experience may also be useful as one of the examples of how complex and expensive cell therapy can be introduced into a national healthcare system. This experience is not universal, but it shows several practical points that may be important for other countries as well. International cooperation on regulatory and funding issues, as well as joint clinical trials of industrial CAR-T technologies, could accelerate the development of this field in the BRICS countries.

1. PubMed database. Accessed 01.06.2026. https://pubmed.ncbi.nlm.nih.gov/?term=CAR-T&sort=pubdate2. Первый пациент МНИОИ им. Герцена получил российскую CAR-T-терапию [The first patient of P. Herzen MORI received Russian CAR-T therapy] (in Russian). Accessed 01.06.2026. https://medvestnik.ru/content/news/Pervyi-pacient-MNIOI-im-Gercena-poluchil-rossiiskuu-CAR-T-terapiu.html?ysclid=mqhtd0tkpm2525814073. Реестр разрешений на проведение клинических исследований [Register of permits for conducting clinical trials] (in Russian). Accessed 01.06.2026. https://grls.minzdrav.gov.ru/CIPermitionReg.aspx4. ClinicalTrials.gov. Accessed 01.06.2026. https://clinicaltrials.gov/search?locStr=Russia&country=RU&intr=CAR-T&viewType=Card5. Первый пациент МНИОИ им. Герцена получил российскую CAR-T-терапию [The first patient of P. Herzen MORI received Russian CAR-T therapy] (in Russian). Accessed 01.06.2026. https://medvestnik.ru/content/news/Pervyi-pacient-MNIOI-im-Gercena-poluchil-rossiiskuu-CAR-T-terapiu.html?ysclid=mqhtd0tkpm2525814076. High-dose chemotherapy, CAR-T, and bone marrow transplantation – all for the sake of saving a patient with aggressive leukemia. Accessed 01.06.2026. https://new.nmicr.ru/en/news/high-dose-chemotherapy-CAR-T-and-bone-marrow-transplantation-all-for-the-sake-of-saving-a-patient-with-aggressive-leukemia/7. Впервые в России два промышленных CAR-T-препарата введены двум детям в Морозовской больнице [For the first time in Russia, two commercial CAR-T drugs were administered to two children at the Morozov Hospital. Moscow Medicine] (in Russian). Accessed 01.06.2026. https://mosgorzdrav.ru/ru-RU/news/default/card/8038.html?ysclid=mnd1fo044l6364639158. Выдача разрешения на производство и применение биомедицинских клеточных продуктов [Register of permits for the production and use of iBMCPs] (in Russian). Accessed 01.06.2026. https://knd.gov.ru/licenses-registry9. Реестр лицензий на производство лекарственных средств. [Register of licenses for the production of medications] (in Russian). Accessed 01.06.2026. https://minpromtorg.gov.ru/opendata/0000000001-LicenziLekarstvaMinpromtorg10. Постановление Правительства Российской Федерации от 29.12.2025 № 2188 «О Программе государственных гарантий бесплатного оказания гражданам медицинской помощи на 2026 год и на плановый период 2027 и 2028 годов» [Decree of the Government of Russia of December 29, 2025 No. 2188 (as amended on April 2, 2026) “On the Program of State Guarantees for the Free Provision of Medical Care to Citizens for 2026 and for the Planning Period of 2027 and 2028”] (in Russian). Accessed 01.06.2026. http://publication.pravo.gov.ru/document/0001202512300036

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The authors declare that there are no conflicts of interest present.