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

January 2, 2024 updated by: SCG Cell Therapy Pte. Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • Hong Kong is.
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong NT
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • Singapore
      • Singapore, Singapore, 169610
        • Recruiting
        • Singapore
      • Singapore, Singapore, 228510
        • Recruiting
        • Singapore
  • United States
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • New York
      • New York, New York, United States, 10065
        • Recruiting
        • New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCG101

This is a single arm study.

Patients will receive infusion and will be observed for dose limiting toxicity (DLT) over a 28-day period, and thereafter enter the progression free survival observation period and continuous long term survival follow up at time of disease progression.
Biological: SCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of SCG101
Time Frame: Start of SCG101 infusion until 100 days post SCG101 infusion
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Start of SCG101 infusion until 100 days post SCG101 infusion
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 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary clinical efficacy of SCG101
Time Frame: Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Objective response rate
Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Antiviral activity before and after SCG101 infusion
Time Frame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
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.
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Time Frame: Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months.
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.
Persistence of viral vector copy number (VCN) after SCG101 infusion
Time Frame: Start of SCG101 infusion until disease progression, an average of 24 months.
Start of SCG101 infusion until disease progression, an average of 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCG Cell Therapy Pte. Ltd.

Investigators

  • Study Director: SCG Cell Therapeutics, SCG Cell Therapy Pte. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCG101-UR-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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