Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLion TCR Pte. Ltd.
About this trial
This is an open-label and multi-center Phase 2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Advanced HCC with diagnosis confirmed by histology/ cytology or clinically by AASLD criteria in cirrhotic patients.
Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
Patients who failed first-line systemic therapy for HCC
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 tumours.
Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
History of severe allergic anaphylactic reactions to T cell therapy products and/or lenvatinib
Trial design
Design model
Sequential
Treatments tested in this trial
LioCyx-M
Biological/VaccineHBV antigen specific TCR redirected T cells
Lenvatinib
Drug12 mg once daily for patients ≥60 kg, 8 mg for patients \<60kg by oral
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: LioCyx-M monotherapyExperimental treatment 1 intervention
Group B: LioCyx-M + lenvatinib combinational therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Assessments of adverse events/serious adverse events
To evaluate the safety of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame
Up to 4 years from study treatment initiation2
Objective response rate (ORR)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame
Up to 4 years from study treatment initiationSecondary outcomes
1
Progression free survival (PFS)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame
Up to 4 years from study treatment initiation2
Time to radiographic progression (TTRP)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame
Up to 4 years from study treatment initiation3
Duration of response (DoR)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame
Up to 4 years from study treatment initiation4
Overall survival (OS)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame
Up to 4 years from study treatment initiationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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