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    DRUG:

    mipetresgene autoleucel (TBI-1301)

    i
    Other names: TBI-1301, NY-ESO-1 antigen-specific T- cell therapy, NY-ESO-1 antigen-specific RetroNectin TCR gene therapy, NY-ESO-1 antigen-specific TCR-gene-transduced autologous lymphocytes, TCR-gene-transduced autologous lymphocytes, TBI 1301, TCR gene transduced autologous lymphocytes, RetroNectin TCR gene therapy, NY-ESO-1 siTCR, TBI-1301-A
    Company:
    Takara
    Drug class:
    TCR modulator, NY ESO 1 inhibitor
    Related drugs:
    2ms
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    1year
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    1year
    Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma (clinicaltrials.gov)
    P1/2, N=8, Completed, Takara Bio Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • mipetresgene autoleucel (TBI-1301)
    1year
    Safety and Efficacy of NY-ESO-1 Antigen-specific T-cell Receptor Gene-Transduced T Lymphocytes in Patients with Synovial Sarcoma: A Phase I/II Clinical Trial. (PubMed, Clin Cancer Res)
    Adoptive immunotherapy with TBI-1301 to selectively target NY-ESO-1 positive tumor cells appears to be a promising strategy for the treatment of advanced or recurrent synovial sarcoma with acceptable toxicity.
    P1/2 data • Journal • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • mipetresgene autoleucel (TBI-1301)
    over1year
    Results from phase I/II study of NY-ESO-1-specific TCR gene-transduced T cell therapy (TBI-1301, mipetresgene autoleucel) in patients with advanced synovial sarcoma. (ASCO 2023)
    TBI-1301 was infused at split dose of 5 x 109 cells following cyclophosphamide treatment at 750 mg/m2 for two days to HLA-A*02:01 or HLA-A*02:06 positive subjects with synovial sarcoma expressing NY-ESO-1, which were surgically unresectable and refractory to anthracycline therapy...All subjects who developed CRS recovered with prespecified treatment, in which 2 subjects were treated with symptomatic therapy, 1 subject was treated with tocilizumab and 1 subject was treated with both tocilizumab and corticosteroid... Adoptive immunotherapy with TBI-1301 to selectively target NY-ESO-1 positive tumors will become a promising treatment for advanced or recurrent synovial sarcoma with acceptable toxicity. Clinical trial information: NCT03250325.
    Clinical • P1/2 data • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • Actemra IV (tocilizumab) • mipetresgene autoleucel (TBI-1301)
    almost2years
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, University Health Network, Toronto | Trial completion date: Sep 2022 --> Sep 2023 | Trial primary completion date: Sep 2022 --> Sep 2023 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    over2years
    NY-ESO-1-specific redirected T cells with endogenous TCR knockdown mediate tumor response and cytokine release syndrome. (PubMed, J Immunother Cancer)
    The trial showed that endogenous TCR-silenced and affinity-enhanced NY-ESO-1 TCR-T cells were safely administered except for grade 3 lung injury. The TCR-T cell infusion exhibited significant tumor response and early-onset CRS in patients with tumors that express NY-ESO-1 at high levels. The differentiation properties of the manufactured T cells may be prognostic for TCR-T-related CRS.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • CTAG1B (Cancer/testis antigen 1B) • CCL2 (Chemokine (C-C motif) ligand 2) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
    |
    CTAG1B expression
    |
    cyclophosphamide • mipetresgene autoleucel (TBI-1301)
    over2years
    The addition of fludarabine to cyclophosphamide for lymphodepleting chemotherapy enhances the persistence of infused NY-ESO-1 TCR anticancer therapy TBI-1301. (ASCO 2022)
    Repeat infusions of TBI-1301 following lymphodepletion appears to be safe and to possess anti-tumor activity. Addition of FLU to the lymphodepletion regimen may contribute to longer persistence of gene-engineered T cells.
    IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    over2years
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Recruiting, University Health Network, Toronto | Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
    Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • mipetresgene autoleucel (TBI-1301)
    over3years
    Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors (clinicaltrials.gov)
    P1, N=22, Recruiting, University Health Network, Toronto | Trial completion date: Jan 2021 --> Sep 2021 | Trial primary completion date: Jan 2021 --> Sep 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    CTAG1B expression
    |
    fludarabine IV • mipetresgene autoleucel (TBI-1301) • cyclophosphamide intravenous