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autologous anti-EBV CAR T cells BRG01
- Development stage
- Phase 1
- Lead developer
- Biosyngen
- Modality
- CAR-Macrophages → Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, CAR-NK Cells → Other Engineered Cells → Adoptive Cell Transfer → Cell Therapies, Bone Marrow HSCs → Hematopoietic Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies, Tumor-Infiltrating Lymphocytes (TILs) → Native Immune Cells → Adoptive Cell Transfer → Cell Therapies, Peripheral Blood HSCs → Hematopoietic Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies, CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, TCR-Engineered T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
- Administration
- Intravenous
01
Overview
BRG01 is an investigational, genetically modified autologous chimeric antigen receptor (CAR) T cell therapy developed by Biosyngen for the treatment of relapsed or metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma. The therapy consists of a patient’s own T lymphocytes that are engineered to express a CAR targeting EBV antigens commonly found on tumor cells in nasopharyngeal carcinoma. This targeted approach enables the modified T cells to recognize and destroy EBV-positive cancer cells. In phase 1 clinical trials conducted in both China and the United States, BRG01 demonstrated excellent safety with no dose-limiting toxicities and showed promising efficacy—75% of high-dose patients experienced local tumor shrinkage and reduced metabolic activity on PET-CT scans, with some achieving complete remission. Additionally, significant reductions in peripheral blood EBV viral load were observed post-infusion. The FDA has granted orphan drug designation and fast track status to BRG01; it is currently being evaluated in pivotal phase 2 trials as the first cell therapy for this indication[1][2][3][4][5][6][7][8].
- Other names
- autologous anti-EBV CAR T cells BRG01
02
Targets
gp350 (Epstein-Barr virus glycoprotein 350)
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