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    DRUG:

    TAEST16001

    i
    Other names: NY-ESO-1-specific T Cell Receptor (TCR) T Cell, TAEST16001, NY-ESO-1-specific TCR affinity enhancing specific T cell therapy, TAEST-16001, TAEST 16001, anti-NY-ESO-1 TCR transduced T cells
    Company:
    Athenex, Guangzhou Xiangxue Pharma
    Drug class:
    TCR modulator, NY ESO 1 inhibitor
    Related drugs:
    over1year
    Phase 1 clinical trial to assess safety and efficacy of NY-ESO-1-specific TCR T cells in HLA-A∗02:01 patients with advanced soft tissue sarcoma. (PubMed, Cell Rep Med)
    Enrolled patients receive TAEST16001 cell infusion after dose-reduced lymphodepletion with cyclophosphamide (15 mg/kg/day × 3 days) combined with fludarabine (20 mg/m/day × 3 days), and the TCR-T cells are maintained with low doses of interleukin-2 injection post-adoptive transfer. The median progression-free survival is 7.2 months, and the median duration of response is 13.1 months. The protocol of TAEST16001 cells delivers a safe and highly effective treatment for patients with advanced soft tissue sarcoma (ClinicalTrials.gov: NCT04318964).
    P1 data • Journal • Metastases
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • IL2 (Interleukin 2)
    |
    HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • TAEST16001
    over1year
    TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Sun Yat-sen University | Trial completion date: Mar 2023 --> May 2024
    Trial completion date
    |
    IL6 (Interleukin 6) • CTAG1B (Cancer/testis antigen 1B)
    |
    TAEST16001
    over1year
    NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> May 2024 | Trial primary completion date: Feb 2023 --> Feb 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • TAEST16001
    2years
    TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2022 --> Apr 2022
    Enrollment closed • Trial primary completion date
    |
    IL6 (Interleukin 6) • CTAG1B (Cancer/testis antigen 1B)
    |
    TAEST16001
    over2years
    Phase II Study of TAEST16001 in Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=70, Recruiting, Sun Yat-sen University
    New P2 trial
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02:01 • HLA-A*02
    |
    TAEST16001
    over2years
    TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=12, Recruiting, Sun Yat-sen University | Trial primary completion date: Mar 2022 --> Sep 2022
    Trial primary completion date
    |
    IL6 (Interleukin 6) • CTAG1B (Cancer/testis antigen 1B)
    |
    TAEST16001
    over2years
    NY-ESO-1-specific T Cell Receptor (TCR) T Cell in Sarcoma (clinicaltrials.gov)
    P1, N=20, Recruiting, Sun Yat-sen University | Trial primary completion date: Feb 2022 --> Feb 2023
    Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • TAEST16001
    over2years
    Phase I clinical trial to assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of NY-ESO-1–specific TCR T-cells (TAEST16001) in HLA-A*02:01 patients with advanced soft tissue sarcoma. (ASCO 2022)
    Prior to TAEST16001 cells infusion, patients were to receive lymphodepleting chemotherapy consisting of cyclophosphamide (15 mg/kg/day ´ 3 days) and fludarabine (20 mg/m2/day ´ 3 days). TAEST16001 cells showed an acceptable tolerability profile overall. MTD was not reached. Emerging efficacy data encouraged the continued expansion study of TAEST16001 cells in advanced soft tissue sarcoma.
    Clinical • P1 data • PK/PD data • IO biomarker
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B) • IL2 (Interleukin 2)
    |
    HLA-A*02:01 • HLA-A*02 • CTAG1B expression
    |
    cyclophosphamide • fludarabine IV • TAEST16001
    3years
    TAEST16001 in the Treatment of Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=12, Recruiting, Sun Yat-sen University | Trial completion date: Jun 2022 --> Mar 2023 | Trial primary completion date: Sep 2021 --> Mar 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    TAEST16001