Clinical trial · Interventional
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
NCT05339321CI-TRIAL-00058378unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD1/PD-L1 checkpoint inhibitor | Biological | — | UNRESOLVED |
| SCG101 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCG101
- description
- SCG101 will be given via Intravenous (IV) infusion.
- interventionNames
- Genetic: SCG101
- type
- EXPERIMENTAL
- label
- SCG101 + PD1/PD-L1 checkpoint inhibitor
- description
- SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
- interventionNames
- Genetic: SCG101
- Biological: PD1/PD-L1 checkpoint inhibitor
Primary outcomes (1)
- measure
- Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed, or imaging diagnosed HCC 2. HLA-A \*02 genotyping 3. HBsAg positive in serum or tumor tissue 4. Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria 5. Child-Pugh score ≤ 7 6. ECOG performance status of 0 or 1 7. Life expectancy of 3 months or greater 8. Patient with adequate organ function Exclusion Criteria: 1. Uncontrolled portal vein or inferior vena cava tumor thrombosis 2. Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases 3. Active or uncontrollable infections 4. History of organ transplantation 5. Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample 6. History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS) 7. Prior exposure to any cell therapy 8. Other severe medical conditions that may limit subject's participation in this trial
References
Publications (2)
- DERIVEDWu X, Quan D, Li W, Wisskirchen K, Wu W, Zhou Y, Liu YP, Wan X, Wang X, Zhang X, Yang L, Zheng M, Zhang K, Protzer U, Du S, Qu X. Clinical results of an HBV-specific T-cell receptor-T-cell therapy (SCG101) in patients with HBV-related hepatocellular carcinoma treated in an investigator-initiated, interventional trial. Gut. 2025 Dec 5;75(1):147-160. doi: 10.1136/gutjnl-2025-335456. PMID 40803751
- DERIVEDWan X, Wisskirchen K, Jin T, Yang L, Wang X, Wu X, Liu F, Wu Y, Ma C, Pang Y, Li Q, Zhang K, Protzer U, Du S. Genetically-modified, redirected T cells target hepatitis B surface antigen-positive hepatocytes and hepatocellular carcinoma lesions in a clinical setting. Clin Mol Hepatol. 2024 Oct;30(4):735-755. doi: 10.3350/cmh.2024.0058. Epub 2024 May 29. PMID 38808361