Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT05417932 (TCR-T) for Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
A Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma (TCR-T) Phase 1, Phase 2 46
Clinical Trial NCT05417932 (TCR-T) is designed to study Treatment for Hepatitis B Virus Related Hepatocellular Carcinoma, Hepatocellular Carcinoma Recurrent. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on October 26, 2022, with plans to enroll 46 participants. Led by SCG Cell Therapy Pte. Ltd., it is expected to complete by October 1, 2025. The latest data from ClinicalTrials.gov was last updated on February 18, 2025.
Brief 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
Detailed 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 an...
Show MoreOfficial Title
A Phase 1/ 2a, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma
Conditions
Hepatitis B Virus Related Hepatocellular CarcinomaHepatocellular Carcinoma RecurrentOther Study IDs
- TCR-T
- SCG101-UR-103
NCT ID Number
Start Date (Actual)
2022-10-26
Last Update Posted
2025-02-18
Completion Date (Estimated)
2025-10
Enrollment (Estimated)
46
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
HCC
Hepatitis B Virus Related
HCC Recurrent
Hepatitis B Virus Related
HCC Recurrent
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSCG101 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 Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Safety and tolerability of SCG101 | Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 | Start of SCG101 infusion until 100 days post SCG101 infusion |
Tumor response of SCG101 (Phase 2) | 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Preliminary clinical efficacy of SCG101 | Objective response rate | Start of SCG101 infusion until a complete response or partial response is observed after 28 days from SCG101 infusion. |
Antiviral activity before and after SCG101 infusion | Based on changes in serum levels of HBsAg | Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months. |
Change in pharmacodynamic markers (PD) before and after SCG101 infusion | Based on changes in serum from the liver function | Start of SCG101 infusion and throughout DLT and PFS until disease progression, an average of 24 months. |
Persistence of viral vector copy number (VCN) after SCG101 infusion | Start of SCG101 infusion until disease progression, an average of 24 months. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
SCG Cell Therapy Pte. Ltd.Study Central Contact
Contact: SCG Cell Therapy, (65) 68297180, [email protected]
6 Study Locations in 3 Countries
New York
New York, New York, New York, 10029, United States
Recruiting
New York, New York, New York, 10065, United States
Recruiting
Hong Kong is., Hong Kong, Hong Kong
Not yet recruiting
Hong Kong NT, Hong Kong, Hong Kong
Recruiting
Singapore, Singapore, 169610, Singapore
Recruiting
Singapore, Singapore, 228510, Singapore
Recruiting