A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related

NCT06617000 | Recruiting Phase 1

• 1 other identifier: SCG-101-CR-102
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 7

Brief Summary

This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC.

Conditions

HCC; Hepatitis B Virus Related Hepatocellular Carcinoma; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).

  Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria

  Start of SCG101 infusion until disease progression or 12 months post infusion

• The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).

  Per mRECIST and iRECIST

  Start of SCG101 infusion until disease progression or 12 months post infusion

• Change in pharmacodynamics markers (PD) before and after SCG101 infusion

  Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP

  Start of SCG101 infusion until disease progression, an average of 24 months

• Persistences of viral vector copy number (VCN) after SCG101 infusion

  Start of SCG101 infusion until disease progression, an average of 24 months

Study Arms (1)

SCG101

EXPERIMENTAL

Biological: SCG101

Interventions

SCG101 BIOLOGICAL

Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.

SCG101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)
• Subjects with HCC who have received standard systemic therapies
• HLA-A \*02
• BCLC stage B or C
• Child-pugh score ≤ 7 ol
• Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml
• Have at least one measurable leasion at baseline as per mRECIST and iRECIST
• Life expectancy of 3 months or greater
• The organ function is in good condition.

You may not qualify if:

• Subjects with history of another primary cancer within 5 years
• Central nervous system metastasis and clinically significant central nervous system disease
• Previous or current coexistence of hepatic encephalopathy
• Currently present with symptomatic third space fluid accumulation
• Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)
• Known history of neurological or mental disorder, including epilepsy or dementia
• Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis
• Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy
• Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection
• Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)
• Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Sponsors & Collaborators

• SCG Cell Therapy Pte. Ltd.: lead

Study Sites (7)

Beijing

Beijing, Beijing Municipality, 100020, China

RECRUITING

Guangzhou

Guangzhou, Guangdong, 510000, China

RECRUITING

Zhengzhou

Zhengzhou, Henan, 450003, China

RECRUITING

Changchun

Changchun, Jilin, 130000, China

RECRUITING

Shenyang

Shenyang, Liaoning, 110000, China

RECRUITING

Ji'nan

Ji'nan, Shandong, 250000, China

RECRUITING

Shanghai

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

SCG Cell Therapy

CONTACT

021-50339500; clinicaltrials@scgcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 27, 2024
• Study Start: October 25, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

CN (7)