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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Genetic: SCG101; Biological: PD1/PD-L1 checkpoint inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05339321

SCG101-CI-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

SCG101

Experimental group

Description:

SCG101 will be given via Intravenous (IV) infusion.

Treatment:

Genetic: SCG101

SCG101 + PD1/PD-L1 checkpoint inhibitor

Experimental group

Description:

SCG101 will be given via Intravenous (IV) infusion. The PD-1/PD-L1 checkpoint inhibitor will be given per product label.

Treatment:

Genetic: SCG101

Biological: PD1/PD-L1 checkpoint inhibitor