A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Hepatocellular Carcinoma Recurrent Clinical Trial

— TCR-T  

Official title:

A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05417932
• Other study ID #: SCG101-UR-103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 26, 2022
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: SCG Cell Therapy Pte. Ltd.
• Contact: SCG Cell Therapy
• Phone: (65) 68297180
• Email: clinicaltrials[@]scgcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels. In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Main Inclusion Criteria:

• 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
• Child-pugh score = 7
• Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
• Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
• Life expectancy of 3 months or greater
• Ability to provide informed consent form
• Ability to comply with all the study procedures

Main Exclusion Criteria:

• 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
• Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
• 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, CAR T/TCR T cell therapy
• Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
• Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatocellular Carcinoma Recurrent

Intervention

Biological:
• SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

Locations

Country	Name	City	State
Hong Kong	Hong Kong is.	Hong Kong
Hong Kong	Hong Kong NT	Hong Kong
Singapore	Singapore	Singapore
Singapore	Singapore	Singapore
Singapore	Singapore	Singapore
United States	New York	New York	New York
United States	New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
SCG Cell Therapy Pte. Ltd.

Countries where clinical trial is conducted

United States,  Hong Kong,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of SCG101	Based on incidence of adverse events (AE) using NCI-CTCAE v5.0	Start of SCG101 infusion until 100 days post SCG101 infusion
Primary	Tumor response of SCG101 (Phase 2)		Start of SCG101 infusion until a complate response or partial response is observed, disease progression, and long term survival follow up up to 15 years
Secondary	Preliminary clinical efficacy of SCG101	Objective response rate	Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Secondary	Antiviral activity before and after SCG101 infusion	Based on changes in serum levels of HBsAg	Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Secondary	Change in pharmacodynamic markers (PD) before and after SCG101 infusion	Based on changes in serum from the liver function	Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
Secondary	Persistence of viral vector copy number (VCN) after SCG101 infusion		Start of SCG101 infusion until disease progression, an average of 24 months.