Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related A… (NCT05339321) | Clinical Trial Compass
UnknownPhase 1
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
China36 participantsStarted 2021-04-14
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed, or imaging diagnosed HCC
✓. HLA-A \*02 genotyping
✓. HBsAg positive in serum or tumor tissue
✓. Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria
✓. Child-Pugh score ≤ 7
✓. ECOG performance status of 0 or 1
✓. Life expectancy of 3 months or greater
✓. Patient with adequate organ function
Exclusion criteria
✕. Uncontrolled portal vein or inferior vena cava tumor thrombosis
✕. Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases
✕. Active or uncontrollable infections
✕. History of organ transplantation
✕. Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample
✕. History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
What they're measuring
1
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)