A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSCG Cell Therapy Pte. Ltd.
About this trial
This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
Subjects with HCC who have received standard systemic therapies
HLA-A *02
BCLC stage B or C
Disqualifiers
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
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
38 Participants
are divided into 1 treatment groupGroup A: SCG101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria
Time frame
Start of SCG101 infusion until disease progression or 12 months post infusion2
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).
Per mRECIST and iRECIST
Time frame
Start of SCG101 infusion until disease progression or 12 months post infusion3
Change in pharmacodynamics markers (PD) before and after SCG101 infusion
Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP
Time frame
Start of SCG101 infusion until disease progression, an average of 24 months4
Persistences of viral vector copy number (VCN) after SCG101 infusion
Time frame
Start of SCG101 infusion until disease progression, an average of 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov