Clinical trial NCT03899415: TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Official title: TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
Collaborators: name: Lion TCR Pte. Ltd.
First posted: 2019-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety evaluation based in Incidences of adverse events/serious adverse events
timeFrame: Up to 1 month after the last infusion
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 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)
measure: Overall survival rate
timeFrame: Up to 5 years from the last infusion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 Hospital of China
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital of China
name: Fusheng Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meng F, Zhao J, Tan AT, Hu W, Wang SY, Jin J, Wu J, Li Y, Shi L, Fu JL, Yu S, Shen Y, Liu L, Luan J, Shi M, Xie Y, Zhou CB, Wong RW, Lu-En W, Koh S, Bertoletti A, Wang T, Zhang JY, Wang FS. Immunotherapy of HBV-related advanced hepatocellular carcinoma with short-term HBV-specific TCR expressed T cells: results of dose escalation, phase I trial. Hepatol Int. 2021 Dec;15(6):1402-1412. doi: 10.1007/s12072-021-10250-2. Epub 2021 Nov 30.