SCG101 for Liver Cancer

(TCR-T Trial)

Recruiting at 10 trial locations

Overseen By SCG Cell Therapy

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SCG Cell Therapy Pte. Ltd.

Must not be taking: Immunosuppressants, Immunotherapy

Disqualifiers: Other cancer, CNS diseases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SCG101, a type of T-cell therapy, for individuals with liver cancer linked to hepatitis B. The main goal is to determine if SCG101 is safe and effective against this cancer type. Participants will receive an infusion of SCG101 and be monitored for side effects. The trial seeks individuals with liver cancer confirmed by tests, who have tried at least two other treatments, and who show specific hepatitis B markers in their blood. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial team for guidance.

Is there any evidence suggesting that SCG101 is likely to be safe for humans?

Research has shown that SCG101 was safe in previous studies. Patients with hepatitis B virus (HBV)-positive recurrent liver cancer tolerated multiple doses of this treatment well, experiencing no serious side effects that required stopping the treatment.

Other studies also found SCG101 effective in reducing HBV infection and combating liver cancer. No major safety issues were reported, indicating that SCG101 is generally well-tolerated.

These findings suggest that SCG101 may be safe for individuals considering participation in a clinical trial with this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SCG101 is unique because it offers a new approach to treating liver cancer by focusing on a specific mechanism that differs from traditional therapies like chemotherapy or targeted drugs. Most treatments for liver cancer aim to shrink tumors or stop their growth, but SCG101 works by potentially enhancing the body's immune response to better recognize and fight cancer cells. Researchers are excited about SCG101 because it could lead to improved outcomes with fewer side effects, offering a promising alternative for patients with limited options.

What evidence suggests that SCG101 might be an effective treatment for liver cancer?

Research has shown that SCG101 holds promise for treating liver cancer linked to hepatitis B. Studies have found that this treatment can shrink tumors and reduce levels of HBsAg, a virus marker, in 94% of patients. The treatment uses T cells, a type of white blood cell, specially modified to find and destroy cancer cells. Early results suggest that side effects remain manageable, which benefits patients. This treatment might offer both virus-fighting and cancer-fighting advantages for those with hepatitis B-related liver cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

SCG Cell Therapeutics

Principal Investigator

SCG Cell Therapy Pte. Ltd.

Are You a Good Fit for This Trial?

This trial is for individuals with liver cancer related to hepatitis B who have tried at least two standard treatments and are expected to live at least three more months. They must have a measurable tumor, be able to consent, and not have HIV/AIDS or other cancers. People with allergies to certain immunotherapies, severe mental disorders, previous cell therapies, untreated brain metastasis, or autoimmune diseases needing strong medication can't join.

Inclusion Criteria

My liver cancer diagnosis was confirmed through tissue examination.

My genetic makeup includes HLA-A *02.

I have a tumor that can be measured by standard medical scans.

Exclusion Criteria

I have had another type of cancer in the past.

I have an autoimmune disease but don't need strong immune-suppressing drugs.

I have not had brain metastasis, liver-related brain issues, or significant brain diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Cohorts of 3-6 subjects are sequentially assigned to escalating dose levels of SCG101 to determine the recommended phase 2 dose (RP2D) based on safety, PK/PD, and antitumor activities

28 days

Multiple visits for dose escalation and monitoring

Phase 2a

Subjects are enrolled to characterize the safety and evaluate the efficacy of SCG101

24 months

Regular visits for safety and efficacy evaluation

Follow-up

Participants are monitored for safety and effectiveness after treatment, including progression-free survival observation and continuous long-term survival follow-up at time of disease progression

100 days post-infusion and ongoing

What Are the Treatments Tested in This Trial?

Interventions

• SCG101

Trial Overview The study tests SCG101's safety and effectiveness in treating hepatitis B-related liver cancer. It's an early-stage (Phase 1/2a) trial involving multiple centers where participants receive the investigational drug SCG101.

How Is the Trial Designed?

Group I: SCG101 Experimental Treatment 1 Intervention

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.

SCG101 is already approved in United States, China for the following indications:

Approved in United States as SCG101 for:

• Hepatitis B virus-related hepatocellular carcinoma

Approved in China as SCG101 for:

• Hepatitis B virus-related hepatocellular carcinoma

Who Is Running the Clinical Trial?

SCG Cell Therapy Pte. Ltd.

Lead Sponsor

Trials

3

Recruited

150+

Published Research Related to This Trial

Chronic hepatitis B virus (HBV) infection poses significant health risks, including cirrhosis and hepatocellular carcinoma (HCC), and current therapies do not typically achieve a functional cure.

Adoptive T-cell immunotherapy, which has shown success in treating B-cell leukemia, may offer a promising new approach for treating both chronic HBV infection and HBV-related HCC by using engineered T cells that target specific HBV or HCC antigens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive T-cell therapy for HBV-associated HCC and HBV infection. Tan, AT., Schreiber, S.[2021]

HBV antigens were found to be expressed in hepatocellular carcinoma (HCC) metastases, indicating that these cancer cells can potentially be targeted by immune therapies.

The study successfully used genetically modified T cells that recognize HBV antigens to reduce HBsAg levels in a patient with chemoresistant HCC, demonstrating the feasibility of this novel therapeutic approach without causing additional liver inflammation or toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of HCC metastases with autologous T cell receptor redirected T cells, targeting HBsAg in a liver transplant patient. Qasim, W., Brunetto, M., Gehring, AJ., et al.[2022]

Chronic viral hepatitis can lead to severe liver damage and liver cancer due to weakened T cell immunity, making it crucial to enhance these immune responses.

Engineering T cells to express virus-specific T cell receptors (TCRs) shows promise as a therapy to boost antiviral responses and may leverage successful strategies from cancer immunotherapy for treating hepatitis-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Viral Liver Diseases: Approaching the Liver Using T Cell Receptor-Mediated Gene Technologies. Healy, K., Pasetto, A., Sobkowiak, MJ., et al.[2021]

In a phase 1 study involving 8 patients with advanced HBV-related hepatocellular carcinoma, HBV-specific TCR redirected T-cell therapy was found to be generally safe, with only one patient experiencing a significant adverse event that resolved without intervention.

The therapy showed promising efficacy, with one patient achieving a partial response lasting 27.7 months and most patients demonstrating reduced levels of HBsAg and HBV DNA, indicating effective anti-tumor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial. Meng, F., Zhao, J., Tan, AT., et al.[2021]

Adoptive transfer of T cells with engineered T cell receptors (TCRs) shows potential as a treatment for hepatocellular carcinoma (HCC), especially since current treatment options are limited.

The study explores the possibility of targeting hepatitis B viral antigens as specific markers for HCC, suggesting that HBV-specific TCR redirected T cells could effectively attack cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T cell receptor-therapy in HBV-related hepatocellularcarcinoma. Bertoletti, A., Brunetto, M., Maini, MK., et al.[2022]

A first-in-man clinical trial showed that T cells redirected to target hepatitis B virus (HBV) antigens can effectively recognize and attack hepatocellular carcinoma (HCC) cells associated with HBV, indicating a promising new approach for treating HBV-related cancers.

The study highlights the potential of using engineered T cell therapy not only for traditional cancers but also for persistent viral infections like HBV, although there are challenges to overcome in developing this immunotherapeutic strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Therapy of Hepatitis B Virus-Related Hepatocellular Carcinoma: Present and Future. Koh, S., Tan, AT., Li, L., et al.[2020]

Citations

1. gut.bmj.com gut.bmj.com/content/early/2025/08/21/gutjnl-2025-335456

Clinical results of an HBV-specific T-cell receptor-T- ... - Gut The study shows that the application of stably HBV-T cell receptor-expressing T cells is effective and side effects are manageable, paving the way for the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40803751/

Clinical results of an HBV-specific T-cell receptor ... Objective: We evaluated the safety, pharmacokinetics, pharmacodynamics and efficacy of SCG101 in patients with HBV-related hepatocellular ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05417932

NCT05417932 | A Study of SCG101 in the Treatment ... A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (TCR-T). ClinicalTrials.gov ID NCT05417932. Sponsor SCG ...

4. onclive.com onclive.com/view/scg101-shows-antiviral-and-antitumor-activity-in-advanced-hbv-related-hcc

SCG101 Shows Antiviral and Antitumor Activity in ... SCG101 therapy showed significant HBsAg reduction and tumor regression in advanced HBV-related HCC patients, with 94% achieving HBsAg level ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/31/18/3886/764542/HBV-Specific-TCR-T-Cell-Therapy-Combining-mRNA

HBV-Specific TCR–T Cell Therapy Combining mRNA ... This study aimed to preliminarily evaluate the safety, tolerability, and antitumor efficacy of hepatitis B virus (HBV)-specific T-cell receptor (TCR)–T cell ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11540345/

Genetically-modified, redirected T cells target hepatitis B ... SCG101 T-cell therapy showed encouraging efficacy and safety in preclinical models and in a patient with primary HBV-HCC and concomitant chronic hepatitis B.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37067675/

Messenger RNA electroporated hepatitis B virus (HBV ... This study has demonstrated that multiple infusions of mRNA electroporated HBV-specific TCR T cells were well-tolerated in patients with HBV-positive recurrent ...