Autologous HBV-specific T Cell Receptor Engineered T Cells (TCR-T) in Patients With HBV-related Advanced HCC

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05339321

Collaborator

(none)

Enrollment

Locations

Arms

31.6

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Genetic: SCG101 Biological: PD1/PD-L1 checkpoint inhibitor	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Clinical Study of Autologous HBV-specific TCR-T Cell Therapy (SCG101) in Patients With HBV-related HCC

Actual Study Start Date :

Apr 14, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SCG101 SCG101 will be given via Intravenous (IV) infusion.	Genetic: SCG101 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.	Genetic: SCG101 SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy. Biological: PD1/PD-L1 checkpoint inhibitor Commercially approved for HCC treatment.

Arm

Intervention/Treatment

Experimental: SCG101

SCG101 will be given via Intravenous (IV) infusion.

Genetic: SCG101

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.

Genetic: SCG101

SCG101 is an autologous HBV-specific T cell receptor engineered T cell therapy.

Biological: PD1/PD-L1 checkpoint inhibitor

Commercially approved for HCC treatment.

Outcome Measures

Primary Outcome Measures

Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT) [28 days]
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 [Up to 2 years]
Tumor response assessment in accordance with mRECIST and iRECIST
Efficacy: antiviral activity of SCG101 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
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

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Principal Investigator: Shunda Du, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05339321

Other Study ID Numbers:

SCG101-CI-101

First Posted:

Apr 21, 2022

Last Update Posted:

May 10, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking Union Medical College Hospital

HCC

Additional relevant MeSH terms:

Carcinoma, Hepatocellular

Study Results

No Results Posted as of May 10, 2022