SCG101 for Liver Cancer

(TCR-T Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: SCG Cell Therapy Pte. Ltd.

Must not be taking: Immunosuppressants, Immunotherapy

Disqualifiers: Other cancer, CNS diseases, HIV, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests SCG101, a new treatment, for safety and effectiveness in patients with liver cancer related to hepatitis B. The study aims to find the best dose that patients can tolerate and how well it works against the cancer. Another treatment being tested shows greater stability and performance over earlier treatments.

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.

What data supports the effectiveness of the treatment SCG101 for liver cancer?

Research shows that using a patient's own T cells, modified to target hepatitis B virus (HBV) antigens, can recognize and attack liver cancer cells associated with HBV. This approach has shown potential in reducing HBV levels and targeting cancer cells without causing significant side effects, suggesting it could be a promising treatment for HBV-related liver cancer. ^{1 2 3 4 5}

Is SCG101 safe for use in humans?

Research on SCG101, also known as HBV TCR-T or Hepatitis B virus TCR T-cell therapy, shows it has been used safely in patients with liver cancer related to hepatitis B. Studies indicate that these engineered T cells did not cause significant liver inflammation or other toxic effects in patients. ^{1 3 4 5 6}

How is the treatment SCG101 for liver cancer different from other treatments?

SCG101 is unique because it uses a patient's own T cells that are genetically modified to specifically target hepatitis B virus (HBV) antigens present in liver cancer cells. This approach aims to harness the body's immune system to recognize and attack cancer cells, offering a novel strategy for treating HBV-related liver cancer, where traditional options are limited. ^{1 2 3 5 6}

Research Team

SCG Cell Therapeutics

Principal Investigator

SCG Cell Therapy Pte. Ltd.

Eligibility Criteria

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.

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

My genetic makeup includes HLA-A *02.

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.

Trial Timeline

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

Treatment Details

Interventions

• SCG101 (Virus Therapy)

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.

Participant Groups

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 China for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Immunotherapy of HCC metastases with autologous T cell receptor redirected T cells, targeting HBsAg in a liver transplant patient. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Therapy of Hepatitis B Virus-Related Hepatocellular Carcinoma: Present and Future. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

T cell receptor-therapy in HBV-related hepatocellularcarcinoma. [2022]

4. United States 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. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Chronic Viral Liver Diseases: Approaching the Liver Using T Cell Receptor-Mediated Gene Technologies. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Adoptive T-cell therapy for HBV-associated HCC and HBV infection. [2021]