Back to resultsAutologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SCG101
PD1/PD-L1 checkpoint inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
- Zhongshan Hospital, Fudan UniversityRecruiting
- The First Hospital of China Medical UniversityRecruiting
- The Sixth People's Hospital of ShenyangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SCG101
SCG101 + PD1/PD-L1 checkpoint inhibitor
Arm Description
SCG101 will be given via Intravenous (IV) infusion.
SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
Outcomes
Primary Outcome Measures
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Secondary Outcome Measures
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Tumor response assessment in accordance with mRECIST and iRECIST
Efficacy: antiviral activity of SCG101
Changes in serum levels of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after SCG101 infusion
Full Information
NCT ID
NCT05339321
First Posted
April 14, 2022
Last Updated
May 7, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05339321
Brief Title
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
Official Title
A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 a natural high-avidity TCR directed towards the HLA-A*02-restricted HBsAg peptide. This is a phase 1 clinical study of SCG101 alone and with PD-1/PD-L1 checkpoint inhibitors in HBV-related HCC.
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. Lymphodepleting regimen of cyclophosphamide and fludarabine will be given prior to SCG101 infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCG101
Arm Type
Experimental
Arm Description
SCG101 will be given via Intravenous (IV) infusion.
Arm Title
SCG101 + PD1/PD-L1 checkpoint inhibitor
Arm Type
Experimental
Arm Description
SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
Intervention Type
Genetic
Intervention Name(s)
SCG101
Intervention Description
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
Intervention Type
Biological
Intervention Name(s)
PD1/PD-L1 checkpoint inhibitor
Intervention Description
Commercially approved for HCC treatment.
Primary Outcome Measure Information:
Title
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
Description
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Description
Tumor response assessment in accordance with mRECIST and iRECIST
Time Frame
Up to 2 years
Title
Efficacy: antiviral activity of SCG101
Description
Changes in serum levels of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after SCG101 infusion
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shunda Du, Doctor
Phone
+86-10-69156114
Email
dushd@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Pang
Phone
+8613601248748
Email
yong.pang@dastarpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shunda Du
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shunda Du
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhong Zhou, Doctor
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Liu
Facility Name
The Sixth People's Hospital of Shenyang
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Wu
12. IPD Sharing Statement
Learn more about this trial
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
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