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

Lion TCR

Status and phase

Enrolling

Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06961617

LTCR-HCC-3-6

Details and patient eligibility

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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