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    DRUG:

    SCG101

    i
    Other names: SCG101, autologous HBV-specific T cell receptor engineered T cell therapy
    Associations

    News

    Trials
    Company:
    SCG Cell Therapy
    Drug class:
    TCR modulator, T-cell stimulant
    Related drugs:
    Associations

    News

    Trials
    6ms
    ANTIVIRAL AND ANTITUMOR EFFECT OF NOVEL HBsAg-SPECIFIC TCR T CELL THERAPY (SCG101) IN PATIENTS WITH HBV-RELATED HEPATOCELLULAR CARCINOMA (AASLD 2023)
    All subjects received a single dose of 5x10e7 or 1x10e8 cells/kg of SCG101 TCR-T cells intravenously after lymphodepletion with cyclophosphamidefludarabine. SCG101, as a single agent, demonstrated significant antiviral and antitumor activity in subjects with HBV-related HCC. The persistence of TCR T cells, reduction of serum HBsAg, and tumor response proved on-target activity of SCG101. A phase I/II clinical trial to systematically evaluate the safety and efficacy of SCG101 has been initiated.
    Clinical • Late-breaking abstract • IO biomarker
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    HLA-A (Major Histocompatibility Complex, Class I, A) • STMN2 (Stathmin 2)
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    HLA-A*02
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    cyclophosphamide • fludarabine IV • SCG101
    7ms
    First-in-human trial of novel HBsAg-specific TCR T cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma (SITC 2023)
    The persistence of TCR+ T cells, reduction of serum HBsAg, and tumor response are strongly correlated with the mechanism of action of SCG101. A phase I/II clinical trial to further evaluate the safety and efficacy of SCG101 is ongoing.
    Clinical • P1 data
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    HLA-A (Major Histocompatibility Complex, Class I, A) • STMN2 (Stathmin 2)
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    HLA-A*02
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    SCG101
    1year
    Autologous cytotoxic T-cell receptor T cell therapy (SCG101) against hepatitis B surface antigen phase I/II trial for patients with advanced hepatitis B-related hepatocellular carcinoma. (ASCO 2023)
    Autologous SCG101 T cell therapy may provide a new treatment option for patients with advanced Hepatitis B virus-related HCC. Clinical trial information: NCT05417932.
    Clinical • P1/2 data • Metastases
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    HLA-A (Major Histocompatibility Complex, Class I, A) • STMN2 (Stathmin 2)
    |
    HLA-A*02
    |
    SCG101
    over1year
    TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=46, Recruiting, SCG Cell Therapy Pte. Ltd. | Initiation date: Jul 2022 --> Oct 2022
    Trial initiation date
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    STMN2 (Stathmin 2)
    |
    SCG101
    over1year
    Enhanced anti-tumor activity of HBsAg specific TCR-T (SCG101) in hepatitis B virus (HBV) related hepatocellular carcinoma (HCC) by preventing T cell exhaustion through PD-1/PD-L1 axis blockade (SITC 2022)
    In vivo, anti-tumor activities were evaluated in HBsAg + PD-L1 + HepG2 cell xenograft mice by i.v. infusing pre-exhausted PD-1 + SCG101 with and without PD-1 (Pembrolizumab) or PD-L1 (Atezolizumab) inhibitors. Procedures used in this study were approved by the Institutional Animal Care and Use Committee (IACUC) at WuXi AppTec (Nantong) Co., Ltd. IACUC serial number: ON01-QD009-2020.
    PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule) • STMN2 (Stathmin 2)
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    HLA-A*02
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    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • SCG101
    almost2years
    TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=46, Recruiting, SCG Cell Therapy Pte. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    STMN2 (Stathmin 2)
    |
    SCG101
    almost2years
    TCR-T: A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (clinicaltrials.gov)
    P1/2, N=46, Not yet recruiting, SCG Cell Therapy Pte. Ltd.
    New P1/2 trial
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    STMN2 (Stathmin 2)
    |
    SCG101
    almost2years
    Antiviral and antitumor activity of SCG101, an autologous HBV-specific T cell receptor engineered T cell (TCR-T) therapy in HBV-related advanced hepatocellular carcinoma (HCC) patients after receiving ≥ 2 prior lines of systemic therapies (EASL-ILC 2022)
    Prior to intravenous infusion of SCG101, patients receive lymphodepleting chemotherapy (fludarabine 25 mg/m2/day and cyclophosphamide 500 mg/m2/day for 3 consecutive days. Systemic SCG101 TCR-T cell therapy was well tolerated and showed promising early signs of clinical efficacy in advanced HBV-related HCC patients who have exhausted available targeted and immunotherapy options. Early and sustained HBsAg reduction demonstrates encouraging antiviral activity with target engagement of SCG101 and might serve as a potential predictive marker of antitumor efficacy. Preliminary data support further systematic clinical evaluation.
    Clinical • PD(L)-1 Biomarker • IO biomarker
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    HLA-A (Major Histocompatibility Complex, Class I, A) • STMN2 (Stathmin 2)
    |
    HLA-A*02 • HLA-A2 positive
    |
    cyclophosphamide • fludarabine IV • SCG101
    2years
    Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC (clinicaltrials.gov)
    P1, N=36, Recruiting, Peking Union Medical College Hospital
    New P1 trial
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    STMN2 (Stathmin 2)
    |
    SCG101