Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-75
SponsorLion TCR Pte. Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options
Serum HBsAg positivity
Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
Disqualifiers
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
Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure
Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.
Trial design
Design model
Single group
Treatments tested in this trial
mRNA HBV/TCR T-cells
DrugStudy Infusion The first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: mRNA HBV/TCR T-cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety evaluation of mRNA HBV/TCR T-cell treatment
Based on incidence and severity of adverse events
Time frame
Start of treatment until 28 days post last dose2
Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment
Histological staining using biopsy and analysis of serum factors such as cytokines and chemokines
Time frame
Start of treatment until end of studySecondary outcomes
1
Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment
Objective response rate (ORR)
Time frame
Up to 4 years2
Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment
Progression free survival (PFS)
Time frame
Up to 4 years3
Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment
Overall survival (OS)
Time frame
Up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov