Phase 1 Hepatitis B Trial, Recruiting NCT06617000 Sponsor: SCG Cell Therapy Pte. Ltd. Condition: Hepatitis B
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Phase 1 Hepatitis B Trial, Recruiting

NCT06617000
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with liver cancer (hepatocellular carcinoma) confirmed by a laboratory test on a tissue or cell sample.
  • You have already received standard treatments for your liver cancer.
  • You have a specific immune system marker called HLA-A*02 (this is a genetic characteristic that can be tested for).
  • Your liver cancer is at a specific stage known as BCLC stage B or C (confirm with trial site).
  • Your liver function score (called Child-Pugh score) is 7 or below, meaning your liver is still working reasonably well.
  • You test negative for HBeAg, positive for HBsAg, and have a low level of hepatitis B virus in your blood or tumor tissue (confirm with trial site for exact values).
  • You have at least one area of cancer that can be measured on a scan at the start of the trial.
  • Your doctors expect you to live for at least 3 months or more.
  • Your major organs (such as kidneys, liver, and heart) are working well enough to participate.

Who may not be able to join:

  • You have been diagnosed with another type of cancer in the past 5 years.
  • Your cancer has spread to your brain or spinal cord, or you have a significant brain condition.
  • You have had or currently have a condition where your liver is affecting your brain function (hepatic encephalopathy).
  • You currently have a buildup of fluid in body cavities (such as your abdomen or chest) that is causing symptoms.
  • You have high blood pressure that cannot be controlled even with medication.
  • You have a known history of a neurological or mental health condition, such as epilepsy or dementia.
  • You have an active autoimmune disease (where your immune system attacks your own body) or another significant immune system condition.
  • You have previously received certain types of cell-based therapies, such as NK cells, CIK cells, dendritic cells, stem cell therapy, or similar treatments.
  • You currently have an active infection with hepatitis C, hepatitis A, hepatitis D, or hepatitis E viruses.
  • You are allergic to immunotherapy drugs or to the chemotherapy medicines used in this trial (cyclophosphamide or fludarabine).
  • The trial doctors believe, for any reason, that joining the trial would not be appropriate for you.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 021-50339500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
SCG Cell Therapy Pte. Ltd.
Registry
ClinicalTrials.gov
Start date
25 October 2022
Est. completion
31 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

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).; 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).; Change in pharmacodynamics markers (PD) before and after SCG101 infusion; Persistences of viral vector copy number (VCN) after SCG101 infusion

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov