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

NCT06961617 | Recruiting Phase 1

• 1 other identifier: LTCR-HCC-3-6
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Assessments of adverse events/serious adverse events

  To evaluate the safety of LioCyx-M

  Start of treatment until 28 days post last dose

• Objective Response Rate (ORR)

  To evaluate the anti-tumor efficacy of LioCyx-M

  Up to 2 years

Secondary Outcomes (3)

• Duration of Response (DoR)

  Up to 2 years

• Progression Free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

Study Arms (1)

LioCyx-M

EXPERIMENTAL

LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10\^6 cells/kg body weight (BW).

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

Interventions

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

Via intravenous (IV) infusion

LioCyx-M

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lion TCR Pte. Ltd.: lead
• Beijing GoBroad Hospital: collaborator

Study Sites (1)

Gaobo Boren Hospital

Beijing, 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

Study Officials

• Tina Wang

  Lion TCR Pte. Ltd.

  STUDY DIRECTOR

Central Study Contacts

Wang Zhe

CONTACT

+86 15902091916; zhe.wang@liontcr.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: May 6, 2025
• First Posted: May 8, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)