A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

September 25, 2024 updated by: SCG Cell Therapy Pte. Ltd.

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

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • 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

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Recruiting
        • Beijing
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Guangzhou
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Zhengzhou
    • Jilin
      • Chang chun, Jilin, China, 130000
        • Recruiting
        • Changchun
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang
    • Shandong
      • Ji'nan, Shandong, China, 250000
        • Recruiting
        • Ji'nan
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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
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
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).
Time Frame: 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
Start of SCG101 infusion until disease progression or 12 months post infusion
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).
Time Frame: Start of SCG101 infusion until disease progression or 12 months post infusion
Per mRECIST and iRECIST
Start of SCG101 infusion until disease progression or 12 months post infusion
Change in pharmacodynamics markers (PD) before and after SCG101 infusion
Time Frame: 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
Start of SCG101 infusion until disease progression, an average of 24 months
Persistences 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.

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 25, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCG-101-CR-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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