- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05339321
Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC
May 7, 2022 updated by: Peking Union Medical College Hospital
A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shunda Du, Doctor
- Phone Number: +86-10-69156114
- Email: dushd@pumch.cn
Study Contact Backup
- Name: Yong Pang
- Phone Number: +8613601248748
- Email: yong.pang@dastarpharma.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Shunda Du
-
Shanghai, China
- Recruiting
- Zhongshan Hospital, Fudan University
-
Contact:
- Yuhong Zhou, Doctor
-
Shenyang, China
- Recruiting
- The First Hospital of China Medical University
-
Contact:
- Yunpeng Liu
-
Shenyang, China
- Recruiting
- The Sixth People's Hospital of Shenyang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SCG101
SCG101 will be given via Intravenous (IV) infusion.
|
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
|
Experimental: SCG101 + PD1/PD-L1 checkpoint inhibitor
SCG101 will be given via Intravenous (IV) infusion.
The PD-1/PD-L1 checkpoint inhibitor will be given per product label.
|
SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.
Commercially approved for HCC treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
Time Frame: 28 days
|
To assess the tolerability of SCG101 and determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D)
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC
Time Frame: Up to 2 years
|
Tumor response assessment in accordance with mRECIST and iRECIST
|
Up to 2 years
|
Efficacy: antiviral activity of SCG101
Time Frame: Up to 2 years
|
Changes in serum levels of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) before and after SCG101 infusion
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shunda Du, Peking Union Medical College Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2021
Primary Completion (Anticipated)
July 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
April 14, 2022
First Submitted That Met QC Criteria
April 14, 2022
First Posted (Actual)
April 21, 2022
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCG101-CI-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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