Hepatocellular Carcinoma
Conditions
Brief summary
This is a single center. single arm, open-label study to determine the safety and clinical benefit of TCR-redirected T cell therapy in patient with HBV related HCC post hepatectomy or radiofrequency ablation.
Interventions
BIOLOGICALTCR redirected T cells
HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10\^4 - 5x10\^6 TCR redirected T cells by IV infusion.
Sponsors
Lion TCR Pte. Ltd.
Beijing 302 Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Expression of the specific human leukocyte antigen (HLA) class I profile 2. Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg) 3. BCLC stage C 4. At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication 5. Laboratory criteria: 1. Liver function: Child A, ALT \< 200 U/L, AST \< 200 U/L, Tbil \< 17.1umol/L 2. Renal Function: Creatinine clearance ≥ 60ml/minute 3. Cardiac Function: No abnormality in cardiac enzyme and ECG 4. Pulmonary Function (Lung): No abnormality in chest X-ray 6. Sexually active subjects must be willing to use an acceptable method of contraception 7. Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures
Exclusion criteria
1. Subject experiencing acute infection or gastric bleeding within 30 days 2. Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7 3. Known history of testing positive for human immunodeficiency virus (HIV) 4. Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease 5. Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy 6. Women who are pregnant or breast-feeding 7. History of allergic reaction to blood products or investigational products 8. History of chronic alcoholism or drug abuse/addiction 9. Require systemic medications, such as steroids during the period of study drug administration 10. Exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy 6 months prior to study drug administration 11. Use of any investigational product (IP) or investigational medical device 12. Any condition which could jeopardize the safety of the patient and his/her compliance in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation based in Incidences of adverse events/serious adverse events | Up to 1 month after the last infusion | Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Start of Treatment until first documented CR or PR, assessed up to 56 treatment weeks (protocol-defined treatment duration is until disease progression, death, or loss to follow up, whichever came first) | Tumour assessment will be according to mRECIST v1.1. This is based on percentage of participants with Complete Response (CR) and Partial Response (PR) according to mRECIST v1.1 from baseline. |
| Overall survival rate | Up to 5 years from the last infusion | Overall Survival (OS) defined as the time from randomisation until death by any cause. Participants will be followed up for survival follow up for at least five years. |
Countries
China
Contacts
Primary ContactMing Shi
Outcome results
None listed