Status:
UNKNOWN
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Adoptive cell therapy with TCR-T cells targeting HBV antigens represents an innovative opportunity for treatment of HBV-related HCC. SCG101 is a genetically modified autologous TCR-T cell therapy with...
Detailed Description
This is an open-label, multi-center clinical study to evaluate the safety, tolerability and effectiveness of SCG101, with and without PD-1/PD-L1 checkpoint inhibitors, in patients with HBV-related HCC...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, or imaging diagnosed HCC
- HLA-A \*02 genotyping
- HBsAg positive in serum or tumor tissue
- Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria
- Child-Pugh score ≤ 7
- ECOG performance status of 0 or 1
- Life expectancy of 3 months or greater
- Patient with adequate organ function
Exclusion
- Uncontrolled portal vein or inferior vena cava tumor thrombosis
- Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases
- Active or uncontrollable infections
- History of organ transplantation
- Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample
- History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
- Prior exposure to any cell therapy
- Other severe medical conditions that may limit subject's participation in this trial
Key Trial Info
Start Date :
April 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05339321
Start Date
April 14 2021
End Date
December 1 2023
Last Update
May 10 2022
Active Locations (4)
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1
Peking Union Medical College Hospital
Beijing, China
2
Zhongshan Hospital, Fudan University
Shanghai, China
3
The First Hospital of China Medical University
Shenyang, China
4
The Sixth People's Hospital of Shenyang
Shenyang, China