Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06961617

Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma

Led by Lion TCR Pte. Ltd. · Updated on 2025-05-08

10

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

Sponsors

L

Lion TCR Pte. Ltd.

Lead Sponsor

B

Beijing GoBroad Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.

CONDITIONS

Official Title

Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of hepatocellular carcinoma by histology, cytology, or clinical diagnosis
  • HCC that cannot be treated with curative surgery or locoregional therapies, or that has progressed after such treatments
  • Has failed at least one systemic therapy for HCC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
  • Positive for hepatitis B surface antigen (HBsAg)
  • Child-Pugh liver function score between 5 and 7 (Class A)
  • Life expectancy of at least 1 year
  • HLA type of either HLA-A02:01 or HLA-A24:02
Not Eligible

You will not qualify if you...

  • Presence of brain metastasis
  • Having a second primary cancer that can be detected clinically at enrollment, except for in situ cervical carcinoma, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer, or superficial bladder tumors
  • Receiving any other anti-cancer treatment including chemotherapy, tyrosine kinase inhibitors, or immunotherapy during the study
  • Use of any investigational drug or device within 28 days before starting study treatment
  • Hepatitis B virus DNA levels equal to or above 200 IU/ml at screening
  • Hepatitis B surface antigen levels equal to or above 10,000 IU/ml at screening
  • Women who are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Gaobo Boren Hospital

Beijing, China

Actively Recruiting

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Research Team

W

Wang Zhe

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma | DecenTrialz