TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
NCT ID: NCT03899415
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2019-04-20
2024-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TCR-Redirected T Cells
HBV antigen specific TCR redirected T cells
TCR 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.
Interventions
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TCR 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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Lion TCR Pte. Ltd.
INDUSTRY
Beijing 302 Hospital
OTHER
Responsible Party
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Principal Investigators
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Fusheng Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital of China
Locations
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Beijing 302 Hospital of China
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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LTCR-HCC-3-1
Identifier Type: -
Identifier Source: org_study_id
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