Adoptive cell therapy with TCR-T cells targeting HBV antigens represents an innovative opportunity for treatment of HBV-related HCC. SCG101 is a genetically modified autologous TCR-T cell therapy with a natural high-avidity TCR directed towards the HLA-A\*02-restricted HBsAg peptide. This is a phase 1 clinical study of SCG101 alone and with PD-1/PD-L1 checkpoint inhibitors in HBV-related HCC.
This is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of SCG101, with and without PD-1/PD-L1 checkpoint inhibitors, in patients with HBV-related HCC. Lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to SCG101 infusion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
Commercially approved for HCC treatment.
Peking Union Medical College Hospital
Beijing, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, China
RECRUITINGNumber of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Time frame: 28 days
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Tumor response assessment in accordance with mRECIST and iRECIST
Time frame: Up to 2 years
Efficacy: antiviral activity of SCG101
Changes in serum levels of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after SCG101 infusion
Time frame: Up to 2 years
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The Sixth People's Hospital of Shenyang
Shenyang, China
RECRUITING