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Virus Therapy
SCG101 for Liver Cancer (TCR-T Trial)
Phase 1 & 2
Recruiting
Research Sponsored by SCG Cell Therapy Pte. Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
TCR-T Trial Summary
This trial is testing a new drug, SCG101, for safety, tolerability, and efficacy in subjects with liver cancer caused by the hepatitis B virus.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of SCG101 aren't listed here, similar drugs often cause immune reactions, fatigue, nausea, potential organ inflammation due to the immune system's response and increased risk of infections.
TCR-T Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer diagnosis was confirmed through tissue examination.
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I have a tumor that can be measured by standard medical scans.
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My genetic makeup includes HLA-A *02.
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I have liver cancer and have undergone at least 2 standard treatments.
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My liver cancer is at an intermediate or advanced stage.
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My hepatitis B virus levels are high, but I don't have active hepatitis.
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My liver function is relatively good.
TCR-T Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of SCG101
Tumor response of SCG101 (Phase 2)
Secondary outcome measures
Antiviral activity before and after SCG101 infusion
Change in pharmacodynamic markers (PD) before and after SCG101 infusion
Persistence of viral vector copy number (VCN) after SCG101 infusion
+1 moreTCR-T Trial Design
1Treatment groups
Experimental Treatment
Group I: SCG101Experimental Treatment1 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.
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Who is running the clinical trial?
SCG Cell Therapy Pte. Ltd.Lead Sponsor
SCG Cell TherapeuticsStudy DirectorSCG Cell Therapy Pte. Ltd.
Christy MaStudy ChairSCG Cell Therapy Pte. Ltd.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had another type of cancer in the past.My liver cancer diagnosis was confirmed through tissue examination.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.I have a tumor that can be measured by standard medical scans.My genetic makeup includes HLA-A *02.I am allergic to certain cancer drugs, including cyclophosphamide and fludarabine.I have liver cancer and have undergone at least 2 standard treatments.I have a history of neurological or mental disorders like epilepsy or dementia.I have not had treatments like CAR T-cell therapy before.My liver cancer is at an intermediate or advanced stage.My hepatitis B virus levels are high, but I don't have active hepatitis.My liver function is relatively good.
Research Study Groups:
This trial has the following groups:- Group 1: SCG101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research undertaking still open to enrolling individuals?
"According to the records hosted on clinicaltrials.gov, this medical trial is open for registration and actively recruiting candidates. This study has been publicly available since October 26th 2022 and was last amended in November 18th of the same year."
Answered by AI
Is this trial accessible to those under the age of 55 years old?
"To qualify for this study, potential participants must fall within the 18 to 70 age range. For those younger than 18 or older than 65, there are 108 and 2800 clinical trials respectively that may be of interest."
Answered by AI
How many people are receiving treatment as part of this clinical trial?
"Affirmative. The details hosted on clinicaltrials.gov verify that this medical experiment, which was first posted on October 26th 2022, is still seeking participants. Approximately 46 patients need to be enrolled from 3 particular sites."
Answered by AI
Am I eligible to partake in this research experiment?
"This trial is actively recruiting 46 subjects between 18 and 70 years of age with a diagnosis of carcinoma. In order to be considered, participants must satisfy additional criteria including: histological or cytological confirmation of hepatocellular carcinoma (HCC); 2 prior standard systemic treatments; HLA-A*02 status; BCLC stage B or C; Child-Pugh score lower than 7; negative serum HBeAg test results; positive serum HBsAg results and HBV-DNA levels at least double 1000 IU/ml ; presence of measurable lesion(s) as per mRECIST & RECIST v1"
Answered by AI
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