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mipetresgene autoleucel
- Development stage
- Phase 2
- Lead developer
- Takara Bio
- Modality
- TCR-Engineered T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Gene Therapies
- Administration
- Intravenous
01
Overview
Mipetresgene autoleucel (TBI-1301) is an autologous T-cell receptor (TCR) gene therapy developed by Takara Bio Inc. for the treatment of NY-ESO-1-positive synovial sarcoma. The therapy consists of patient-derived T lymphocytes genetically modified using a retroviral vector (siTCR vector) to express an affinity-enhanced TCR specific for the NY-ESO-1 cancer-testis antigen, restricted to HLA-A*02:01 or HLA-A*02:06. To improve efficacy and safety, the vector also includes siRNA constructs designed to downregulate the expression of endogenous TCRs, thereby reducing TCR mispairing and enhancing the surface expression of the therapeutic TCR. It is currently in Phase 3 development in Japan, where it has received Sakigake and orphan drug designations.
- Brand names
- Mip-cel
- Other names
- mipetresgene autoleucelTBI-1301TBI1301TBI 1301Mip-cel
02
Targets
HLA-A*02 (Human leukocyte antigen A*02 complexed peptide)
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