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

NCT05417932 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SCG101-UR-103
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 6

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

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma; Hepatocellular Carcinoma Recurrent

Keywords

HCC; Hepatitis B Virus Related; HCC Recurrent

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Preliminary clinical efficacy of SCG101

  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

  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

  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

  Start of SCG101 infusion until disease progression, an average of 24 months.

Study Arms (1)

SCG101

EXPERIMENTAL

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

Interventions

SCG101 BIOLOGICAL

Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

SCG101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SCG Cell Therapy Pte. Ltd.: lead

Study Sites (6)

New York

New York, New York, 10029, United States

RECRUITING

New York

New York, New York, 10065, United States

RECRUITING

Hong Kong is.

Hong Kong, Hong Kong

NOT YET RECRUITING

Hong Kong NT

Hong Kong, Hong Kong

RECRUITING

Singapore

Singapore, 169610, Singapore

RECRUITING

Singapore

Singapore, 228510, Singapore

RECRUITING

Study Officials

• SCG Cell Therapeutics

  SCG Cell Therapy Pte. Ltd.

  STUDY DIRECTOR

Central Study Contacts

SCG Cell Therapy

CONTACT

(65) 68297180; clinicaltrials@scgcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SCG101 in the Treatment of Subjects with Hepatitis B Virus-Related Hepatocellular Carcinoma

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 14, 2022
• Study Start: October 26, 2022
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2); US (2); HK (2)