A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
SCG Cell Therapy Pte. Ltd.
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
Description
This study will be conducted in 2 parts: In Phase 1 dose escalation, cohorts of 3-6 subjects each will be sequentially assigned to escalating dose level of SCG101. The recommended phase 2 dose (RP2D) will be selected based on the safety, PK/ PD and antitumor activities if the maximum tolerated dose (MTD) is not reached from the planned dose levels. In Phase 2a, subjects will be enrolled to characterize the safety and evaluate the efficacy of SCG101.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion 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 Main Exclusion Criteria: * Subject…
Interventions
- BiologicalSCG101
Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.
Locations (6)
- New YorkNew York, New York
- New YorkNew York, New York
- Hong Kong is.Hong Kong
- Hong Kong NTHong Kong
- SingaporeSingapore
- SingaporeSingapore