RECRUITING

A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Conditions

Hepatitis B Virus Related Hepatocellular Carcinoma Hepatocellular Carcinoma Recurrent HCC Hepatitis B Virus Related HCC Recurrent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Phase 1/ 2a study is a multicenter study to evaluate the safety, tolerability and efficacy of SCG101 in subjects with hepatitis B virus-related hepatocellular carcinoma

Official Title

A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma

Quick Facts

Study Start:2022-10-26

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05417932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC) * Subjects with HCC who have received at least 2 standard systemic therapies * HLA-A \02 BCLC stage B or C * Child-pugh score ≤ 7 * Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml * Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria * Life expectancy of 3 months or greater * Ability to provide informed consent form * Ability to comply with all the study procedures	* Subjects with history of another primary cancer * Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases * Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection * Known history of neurological or mental disorder, including epilepsy or dementia * Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS) * Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T/TCR T cell therapy * Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine) * Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents * Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Inclusion Criteria

Exclusion Criteria

* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
* Subjects with HCC who have received at least 2 standard systemic therapies
* HLA-A \*02
* BCLC stage B or C
* Child-pugh score ≤ 7
* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be 2 × 1000 IU/ml
* Have at least one measurable leasion at baseline as per mRECIST and RECIST v1.1 criteria
* Life expectancy of 3 months or greater
* Ability to provide informed consent form
* Ability to comply with all the study procedures

* Subjects with history of another primary cancer
* Untreated or active central nervous system (CNS) or leptomeningeal metastasis, or history of hepatic encephalopathy, or other clinically significant CNS diseases
* Autoimmune diseases requiring immunosuppressive therapy (except topical medication) or subjects with significant persistent immune rejection
* Known history of neurological or mental disorder, including epilepsy or dementia
* Known history of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy, CAR T/TCR T cell therapy
* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
* Any subjects who cannot be evaluated by either triphasic liver CT or triphasic MRI because of allergy or other contraindication to both CT and MRI contrast agents
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Contacts and Locations

Study Contact

SCG Cell Therapy

CONTACT

(65) 68297180

clinicaltrials@scgcell.com

Principal Investigator

SCG Cell Therapeutics

STUDY_DIRECTOR

SCG Cell Therapy Pte. Ltd.

Study Locations (Sites)

New York

New York, New York, 10029

United States

New York

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: SCG Cell Therapy Pte. Ltd.

SCG Cell Therapeutics, STUDY_DIRECTOR, SCG Cell Therapy Pte. Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-26

Study Completion Date2025-10

Study Record Updates

Study Start Date2022-10-26

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

HCC
Hepatitis B Virus Related
HCC Recurrent

Additional Relevant MeSH Terms

Hepatitis B Virus Related Hepatocellular Carcinoma
Hepatocellular Carcinoma Recurrent