Photo: Dizal Pharma
The Chinese investigational drug will be evaluated in 71 lymphoma patients with refractory disease. This multicenter clinical trial will be conducted at 14 Russian medical centers located in Moscow and other regions throughout Russia.
Standard treatments for B-cell non-Hodgkin lymphoma, including ibrutinib and acalabrutinib, function by inhibiting a specific intracellular signaling protein called Bruton's tyrosine kinase (BTK). This mechanism prevents malignant cell proliferation.
The potential advantage of birlentinib that investigators aim to validate is its dual inhibition of two proteins—BTK and LYN kinase. Additionally, the drug demonstrates reversible binding to tumor cells (in contrast to older irreversible BTK inhibitors), which theoretically may reduce adverse effects. The active compound also achieves central nervous system penetration—a critical feature when tumors have metastasized to the CNS.
In earlier phase studies involving 61 patients, the drug achieved tumor reduction or disease stabilization in approximately 57.9% of subjects. Investigators observed typical adverse events associated with this drug class, including thrombocytopenia and leukopenia, and have planned additional safety monitoring during the trials.
Trial Sites:
- Bashkir State Medical University, Ufa
- City Hospital No. 15, St. Petersburg
- Kirov Research Institute of Hematology and Blood Transfusion, Kirov
- Komi Republican Clinical Oncology Center, Syktyvkar
- Regional Clinical Hospital, Krasnoyarsk
- Leningrad Regional Clinical Hospital, St. Petersburg
- MMCC "Kommunarka," Moscow
- S.P. Botkin Clinical Hospital, Moscow
- N.A. Semashko Regional Clinical Hospital, Nizhny Novgorod
- R.M. Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, St. Petersburg
- V.A. Almazov National Medical Research Center, St. Petersburg
- 4D Ultrasound Clinic LLC, Pyatigorsk
- V.A. Baranov Republican Hospital, Petrozavodsk
- Samara State Medical University, Samara
For patients with treatment-refractory lymphomas, additional therapeutic options are currently available in Russia. CAR-T cell therapy represents a contemporary treatment modality for patients with B-cell lymphomas. In CAR-T therapy, patients receive personalized treatment with genetically modified autologous T-cells engineered to target and destroy tumor cells. Marus Media has published a comprehensive review of this treatment approach.
Marus Media has also previously reported that Russia is conducting research on personalized vaccines for the treatment of melanoma and metastatic colorectal cancer. The personalized mRNA vaccine for melanoma therapy is being developed by the National Medical Research Radiological Center in collaboration with the Gamaleya National Research Center of Epidemiology and Microbiology and the N.N. Blokhin National Medical Research Center of Oncology. The second vaccine is being developed and manufactured at Federal Medical-Biological Agency institutions, with the primary investigational site being the Yu.M. Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine.
Source: GLRS
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