The National Medical Research Centre for Haematology is preparing Russia’s first CAR–T cell therapy that will be available to patients nationwide, said Apollinaria Bogolyubova‑Kuznetsova, head of the centre’s biomedical technology department. A dossier for conditional registration of the new CAR–T drug is already being prepared, while clinical trials continue in parallel to assess its long–term efficacy, she said.
“The CAR–T drug is currently available both as a high‑tech medicinal product and as an individual medical cell product. As a medicinal product, it has completed its first Phase I/II clinical trial, which involved patients with relapsed and refractory B‑cell malignancies. A personalised CAR–T cell product was manufactured for each patient, and therapy efficacy was assessed on day 28 after administration,” the expert explained.
Another clinical trial is now underway to evaluate the therapy’s effectiveness over the course of one year after administration. The researchers expect to obtain results by the end of 2026, Bogolyubova–Kuznetsova added.
She also noted that all stages of the drug’s development, from research to clinical trials, were carried out at the NMRC for Haematology. The production facility is also located on site.
“This approach is expected to significantly ease the task of making the drug broadly accessible,” she stressed.
The expert also pointed to the importance of the CAR–T drug being registrable as a medicinal product, rather than solely as an individual biomedical cell product.
