A Phase 1 interventional study of SCG101 and PD1/PD-L1 checkpoint inhibitor in Hepatocellular Carcinoma, sponsored by Peking Union Medical College Hospital. Status unknown at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by Peking Union Medical College Hospital · Phase 1, Interventional, and Treatment
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's planned enrollment of 36 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SCG101 will be given via Intravenous (IV) infusion.
Genetic: SCG101
SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
Genetic: SCG101 · Biological: PD1/PD-L1 checkpoint inhibitor
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
Commercially approved for HCC treatment.
Number 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
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital