Recurrent Hepatocellular Carcinoma
Conditions
Brief summary
This is a single-arm and open-label study to assess the safety, tolerability and primary efficacy of the HBV specific T cell receptor (HBV/TCR) redirected T cell in patients with recurrent Hepatitis B virus (HBV) related hepatocellular carcinoma post liver transplantation.
Interventions
BIOLOGICALTCR-T cells
Patients will receive 1 x 10\^4 cells/kg to 5 x 10\^6 cells/kg bodyweight of TCR redirected T cells by IV infusion.
Sponsors
Lion TCR Pte. Ltd.
Xiaoshun He
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis as hepatocellular carcinoma (HCC). 2. Recurrent locally advanced and/or metastatic hepatocellular carcinoma (HCC) post liver transplantation. 3. Seropositive for hepatitis B surface antigen, or presence of HBV DNA or HBV RNA. 4. HLA profile matching with HLA-class I restriction element of the available T cell receptors. 5. ECOG performance status ≤ 2. 6. Laboratory criteria: 1. Liver function: ALT and AST ≤ 5 of upper limit of normal (ULN), TBIL ≤ 3 x ULN. 2. Neutrophil cell number ≥1.5×10\^9/L. 3. Platelet count ≥100×10\^9/L. 7. Ability to provide informed consent. 8. Willing and able to comply with all study procedures.
Exclusion criteria
1. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment. 2. Likelihood to require steroid treatment during the period of the clinical trial. 3. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples. 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 5. Administration of any other cell therapy, including NK, CIK, DC, CTL, CAR- T, stem cells or combined therapy of the kind within 28 days prior to start of treatment. 6. Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation of the TCR-T treatment | Start of Treatment until 28 days post last dose | Incidence of adverse events/serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Start of treatment until disease progression, and subsequent follow up up to 24 months post treatment. | Tumour assessment will be according to RECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to RECIST v1.1 from baseline. |
| Progression-free survival (PFS) | Start of treatment until disease progression, and at 6-month and 1-year. | 1-year PFS is measured by the number of patients with stable disease after 1 year, using RECIST v1.1. |
| Overall survival (OS) | Start of treatment until disease progression, and at 6-month and 1-year. | OS is defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for two years. |
Countries
China
Outcome results
None listed