A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
New York
RECRUITING
New York
New York
RECRUITING
New York
Other Locations
Hong Kong Special Administrative Region
Hong Kong is.
NOT_YET_RECRUITING
Hong Kong
Hong Kong NT
RECRUITING
Hong Kong
Singapore
Singapore
RECRUITING
Singapore
Singapore
RECRUITING
Singapore
Contact Information
Primary
SCG Cell Therapy
clinicaltrials@scgcell.com
(65) 68297180
Time Frame
Start Date: 2022-10-26
Estimated Completion Date: 2025-10
Participants
Target number of participants: 46
Treatments
Experimental: SCG101
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.
Related Therapeutic Areas
Sponsors
Leads: SCG Cell Therapy Pte. Ltd.