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NCT Number: NCT06961617

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HCC diagnosis confirmed by histology/ cytology or clinically
  • HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
  • Has failed at least one line of systemic therapy for HCC
  • ECOG performance status ≤1
  • Serum HBsAg positivity
  • Child-Pugh A (5 - 7 points)
  • Life expectancy of at least 1 year
  • HLA profile: HLA-A*02:01 or HLA-A*24:02

Exclusion criteria

  • Brain metastasis
  • Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors
  • Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.
  • Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration
  • Serum HBV DNA levels ≥ 200 IU/ml at screening
  • Serum HBsAg levels ≥ 10,000 IU/ml at screening
  • Women who are pregnant or breast-feeding

Treatment and study plan

LioCyx-M, HBV antigen-specific TCR-redirected T cells

Drug

Via intravenous (IV) infusion

Primary outcomes

  1. Assessments of adverse events/serious adverse events

    Time frame: Start of treatment until 28 days post last dose

    To evaluate the safety of LioCyx-M

  2. Objective Response Rate (ORR)

    Time frame: Up to 2 years

    To evaluate the anti-tumor efficacy of LioCyx-M

Secondary outcomes

  1. Duration of Response (DoR)

    Time frame: Up to 2 years

    To evaluate the anti-tumor efficacy of LioCyx-M

  2. Progression Free Survival (PFS)

    Time frame: Up to 2 years

    To evaluate the anti-tumor efficacy of LioCyx-M

  3. Overall Survival (OS)

    Time frame: Up to 2 years

    To evaluate the anti-tumor efficacy of LioCyx-M

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Zhe

CONTACT

[email protected]

+86 15902091916

Sponsors and collaborators

Lead sponsor

Lion TCR Pte. Ltd.

Industry

Collaborators

  • Beijing GoBroad Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 8, 2025
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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