Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLion TCR Pte. Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
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
Trial design
Design model
Single group
Treatments tested in this trial
LioCyx-M, HBV antigen-specific TCR-redirected T cells
DrugVia intravenous (IV) infusion
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: LioCyx-MExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessments of adverse events/serious adverse events
To evaluate the safety of LioCyx-M
Time frame
Start of treatment until 28 days post last dose2
Objective Response Rate (ORR)
To evaluate the anti-tumor efficacy of LioCyx-M
Time frame
Up to 2 yearsSecondary outcomes
1
Duration of Response (DoR)
To evaluate the anti-tumor efficacy of LioCyx-M
Time frame
Up to 2 years2
Progression Free Survival (PFS)
To evaluate the anti-tumor efficacy of LioCyx-M
Time frame
Up to 2 years3
Overall Survival (OS)
To evaluate the anti-tumor efficacy of LioCyx-M
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lion TCR Pte. Ltd.
Lead sponsor
Beijing GoBroad Hospital
Collaborator
Source ClinicalTrials.gov