SCG101

P1, N=38, Recruiting, SCG Cell Therapy Pte. Ltd.

Transferred T cells expanded, developed a stem cell-like memory phenotype, and were still detectable after six months in the patient's blood. SCG101 T-cell therapy showed encouraging efficacy and safety in pre-clinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B with the capability to eliminate HBsAg+ cells and achieve sustained tumor control after single dosing.

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.

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.

Autologous SCG101 T cell therapy may provide a new treatment option for patients with advanced Hepatitis B virus-related HCC. Clinical trial information: NCT05417932.

P1/2, N=46, Recruiting, SCG Cell Therapy Pte. Ltd. | Initiation date: Jul 2022 --> Oct 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.

P1/2, N=46, Recruiting, SCG Cell Therapy Pte. Ltd. | Not yet recruiting --> Recruiting

P1/2, N=46, Not yet recruiting, SCG Cell Therapy Pte. Ltd.

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.

P1, N=36, Recruiting, Peking Union Medical College Hospital