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

Primary Purpose

Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SCG101
Sponsored by
SCG Cell Therapy Pte. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B Virus Related Hepatocellular Carcinoma focused on measuring HCC, Hepatitis B Virus Related, HCC Recurrent

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New YorkRecruiting
  • New YorkRecruiting
  • Hong Kong is.Recruiting
  • Hong Kong NT
  • SingaporeRecruiting
  • SingaporeRecruiting
  • Singapore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCG101

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety and tolerability of SCG101
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Tumor response of SCG101 (Phase 2)

Secondary Outcome Measures

Preliminary clinical efficacy of SCG101
Objective response rate
Antiviral activity before and after SCG101 infusion
Based on changes in serum levels of HBsAg
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Based on changes in serum from the liver function
Persistence of viral vector copy number (VCN) after SCG101 infusion

Full Information

First Posted
May 24, 2022
Last Updated
October 6, 2023
Sponsor
SCG Cell Therapy Pte. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05417932
Brief Title
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Acronym
TCR-T
Official Title
A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCG Cell Therapy Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent
Keywords
HCC, Hepatitis B Virus Related, HCC Recurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCG101
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
SCG101
Intervention Description
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Primary Outcome Measure Information:
Title
Safety and tolerability of SCG101
Description
Based on incidence of adverse events (AE) using NCI-CTCAE v5.0
Time Frame
Start of SCG101 infusion until 100 days post SCG101 infusion
Title
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
Secondary Outcome Measure Information:
Title
Preliminary clinical efficacy of SCG101
Description
Objective response rate
Time Frame
Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion.
Title
Antiviral activity before and after SCG101 infusion
Description
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.
Title
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Description
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.
Title
Persistence of viral vector copy number (VCN) after SCG101 infusion
Time Frame
Start of SCG101 infusion until disease progression, an average of 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SCG Cell Therapy
Phone
(65) 68297180
Email
clinicaltrials@scgcell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SCG Cell Therapeutics
Organizational Affiliation
SCG Cell Therapy Pte. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
New York
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Hong Kong is.
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Hong Kong NT
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Singapore
City
Singapore
ZIP/Postal Code
228510
Country
Singapore
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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