Study on SCG101 for Treating Liver Cancer Related to Hepatitis B Virus

Sponsor: SCG Cell Therapy Pte. Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05417932

Provider View

This clinical trial is testing a new treatment called SCG101 to see if it is safe and effective for patients with liver cancer caused by the hepatitis B virus. The study is being conducted in multiple locations and involves two phases.

Patient Parameters

Program Overview

This study is being conducted in two parts. In the first part, researchers will test different doses of SCG101 to find the safest and most effective dose. In the second part, they will further evaluate the safety and effectiveness of SCG101 in patients with liver cancer related to hepatitis B virus.

Description

The study is divided into two phases. In Phase 1, small groups of patients will receive increasing doses of SCG101 to determine the safest dose that can be used in future studies. This phase will help identify the recommended dose for Phase 2 if the maximum safe dose is not reached.

In Phase 2a, more patients will be enrolled to further assess the safety and effectiveness of SCG101 in treating liver cancer related to hepatitis B virus. Researchers will monitor how well the treatment works and any side effects that occur.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of liver cancer (hepatocellular carcinoma).
  • Have received at least two standard treatments for liver cancer.
  • Have a specific genetic marker called HLA-A*02.
  • Be in stage B or C of liver cancer according to the BCLC staging system.
  • Have a Child-Pugh score of 7 or less, indicating liver function.
  • Have negative serum HBeAg, positive serum or tumor tissue HBsAg, and serum HBV-DNA levels of at least 2000 IU/ml.
  • Have at least one measurable tumor at the start of the study.
  • Have a life expectancy of at least 3 months.
  • Be able to provide informed consent and comply with study procedures.

Exclusion Criteria

  • Have a history of another type of cancer.
  • Have untreated or active cancer spread to the brain or spinal cord, or a history of liver-related brain issues.
  • Have autoimmune diseases requiring immunosuppressive therapy, except for topical treatments.
  • Have a history of neurological or mental disorders, such as epilepsy or dementia.
  • Have a known history of HIV or AIDS.
  • Have previously received any type of cell therapy, such as NK cells, CIK cells, DC, CTL, stem cell therapy, or CAR T/TCR T cell therapy.
  • Have allergies to immunotherapy drugs or certain chemotherapy drugs (cyclophosphamide and fludarabine).
  • Cannot undergo liver imaging tests due to allergies or other reasons.
  • Have any condition that the investigator believes makes the patient unsuitable for the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.