Actively Recruiting

Phase 1
Age: 21Years - 75Years
All Genders
NCT04745403

Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)

Led by Lion TCR Pte. Ltd. · Updated on 2023-11-18

10

Participants Needed

1

Research Sites

319 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.

CONDITIONS

Official Title

Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Primary hepatocellular carcinoma in the liver with measurable tumor by RECIST 1.1 criteria, not amenable to or failed conventional treatment
  • Positive serum hepatitis B surface antigen (HBsAg)
  • Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
  • Life expectancy of at least 3 months
  • HLA class I profile matching HLA-A02:01 or HLA-A24:02 restriction element of available T cell receptors
  • Age between 21 and 75 years
Not Eligible

You will not qualify if you...

  • Presence of brain metastasis
  • Second primary malignancy clinically detectable at enrollment, except specified localized cancers
  • Use of immune checkpoint inhibitors or tyrosine kinase inhibitors within 5 half-lives prior to baseline liver biopsy
  • Changes in concomitant medications causing potential liver injury within 3 months before baseline liver biopsy
  • Likelihood of requiring immunosuppressive treatments during the trial
  • Last RFA/TACE treatment within 3 months or Y90 therapy within 6 months before first infusion
  • Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)
  • Concurrent anti-tumor therapies including chemotherapy, hormonal therapy, or immunotherapy
  • Use of investigational products or devices within 30 days before study drug administration
  • Serum HBV DNA levels ≥ 200 IU/ml at screening
  • Serum HBsAg levels ≥ 10,000 IU/ml at screening
  • Lack of venous access or conditions interfering with drug administration or sample collection
  • Any condition or active infections deemed unsuitable by investigator
  • 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

Singapore General Hospital

Singapore, Singapore, 169608

Actively Recruiting

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Research Team

R

Royce Fam

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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