Recruiting
Phase 1
Phase 2

SCG101

Sponsor:

SCG Cell Therapy Pte. Ltd.

Code:

NCT05417932

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma

Hepatocellular Carcinoma Recurrent

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

SCG101

Study Details

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

Study ID

NCT05417932

Start date

Oct 26, 2022

Status verified date

Feb, 2025

Completion date

Oct, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

46 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

SCG101

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

Primary outcome measure

  • Safety and tolerability of SCG101 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

SCG Cell Therapy

(65) 68297180clinicaltrials@scgcell.com

Locations

New York

Recruiting

New York, New York, United States, 10029

New York

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

SCG Cell Therapy Pte. Ltd.

Last update posted

Feb 18, 2025

Last verified

Feb, 2025

Keywords

  • HCC
  • Hepatitis B Virus Related
  • HCC Recurrent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SCG Cell Therapy Pte. Ltd. on 2025-02-18.