A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSCG Cell Therapy Pte. Ltd.
About this trial
This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
Subjects with HCC who have received at least 2 standard systemic therapies
HLA-A *02
BCLC stage B or C
Disqualifiers
Subjects with history of another primary cancer
Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
Known history of neurological or mental disorder, including epilepsy or dementia
Trial design
Design model
Single group
Treatments tested in this trial
SCG101
Biological/VaccineInfusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Treatment groups
46 Participants
are divided into 1 treatment groupGroup A: SCG101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of SCG101
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Time frame
Start of SCG101 infusion until 100 days post SCG101 infusion2
Tumor response of SCG101 (Phase 2)
Time frame
Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 yearsSecondary outcomes
1
Preliminary clinical efficacy of SCG101
Objective response rate
Time frame
Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.2
Antiviral activity before and after SCG101 infusion
Based on changes in serum levels of HBsAg
Time frame
Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.3
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Based on changes in serum from the liver function
Time frame
Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.4
Persistence of viral vector copy number (VCN) after SCG101 infusion
Time frame
Start of SCG101 infusion until disease progression, an average of 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov