HCC, Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma
Conditions
Brief summary
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Interventions
BIOLOGICALSCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Sponsors
SCG Cell Therapy Pte. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC) * Subjects with HCC who have received standard systemic therapies * HLA-A \*02 * BCLC stage B or C * Child-pugh score ≤ 7 ol * Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml * Have at least one measurable leasion at baseline as per mRECIST and iRECIST * Life expectancy of 3 months or greater * The organ function is in good condition.
Exclusion criteria
* Subjects with history of another primary cancer within 5 years * Central nervous system metastasis and clinically significant central nervous system disease * Previous or current coexistence of hepatic encephalopathy * Currently present with symptomatic third space fluid accumulation * Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment) * Known history of neurological or mental disorder, including epilepsy or dementia * Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis * Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy * Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection * Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine) * Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). | Start of SCG101 infusion until disease progression or 12 months post infusion | Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria |
| The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). | Start of SCG101 infusion until disease progression or 12 months post infusion | Per mRECIST and iRECIST |
| Change in pharmacodynamics markers (PD) before and after SCG101 infusion | Start of SCG101 infusion until disease progression, an average of 24 months | Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP |
| Persistences of viral vector copy number (VCN) after SCG101 infusion | Start of SCG101 infusion until disease progression, an average of 24 months | — |
Countries
China
Contacts
Primary ContactSCG Cell Therapy
Outcome results
None listed