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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339321
• Other study ID #: SCG101-CI-101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 14, 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: Shunda Du, Doctor
• Phone: +86-10-69156114
• Email: dushd[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed, or imaging diagnosed HCC

2. HLA-A *02 genotyping

3. HBsAg positive in serum or tumor tissue

4. Have at least one measurable lesion at baseline as per mRECIST and RECIST v1.1 criteria

5. Child-Pugh score = 7

6. ECOG performance status of 0 or 1

7. Life expectancy of 3 months or greater

8. Patient with adequate organ function

Exclusion Criteria:

1. Uncontrolled portal vein or inferior vena cava tumor thrombosis

2. Untreated or active Central nervous system (CNS) metastasis or other clinically significant CNS diseases

3. Active or uncontrollable infections

4. History of organ transplantation

5. Lack of peripheral or central venous access or any condition that would interfere with study drug administration or collection of study sample

6. History of positive results for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)

7. Prior exposure to any cell therapy

8. Other severe medical conditions that may limit subject's participation in this trial

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Zhongshan Hospital, Fudan University	Shanghai
China	The First Hospital of China Medical University	Shenyang
China	The Sixth People's Hospital of Shenyang	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	28 days
Secondary	Efficacy: antitumor activity of SCG101 in subjects with HBV-related HCC	Tumor response assessment in accordance with mRECIST and iRECIST	Up to 2 years
Secondary	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	Up to 2 years