Hepatocellular Carcinoma
Conditions
Keywords
HCC
Brief 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.
Detailed description
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.
Interventions
GENETICSCG101
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
BIOLOGICALPD1/PD-L1 checkpoint inhibitor
Commercially approved for HCC treatment.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT) | 28 days | To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC | Up to 2 years | Tumor response assessment in accordance with mRECIST and iRECIST |
| Efficacy: antiviral activity of SCG101 | Up to 2 years | Changes in serum levels of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after SCG101 infusion |
Countries
China
Contacts
Primary ContactShunda Du, Doctor
Backup ContactYong Pang
Outcome results
None listed