TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TCR redirected T cells
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Expression of the specific human leukocyte antigen (HLA) class I profile
- Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
- BCLC stage C
- At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
Laboratory criteria:
- Liver function: Child A, ALT < 200 U/L, AST < 200 U/L, Tbil < 17.1umol/L
- Renal Function: Creatinine clearance ≥ 60ml/minute
- Cardiac Function: No abnormality in cardiac enzyme and ECG
- Pulmonary Function (Lung): No abnormality in chest X-ray
- Sexually active subjects must be willing to use an acceptable method of contraception
- 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:
- Subject experiencing acute infection or gastric bleeding within 30 days
- Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7
- Known history of testing positive for human immunodeficiency virus (HIV)
- Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease
- Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy
- Women who are pregnant or breast-feeding
- History of allergic reaction to blood products or investigational products
- History of chronic alcoholism or drug abuse/addiction
- Require systemic medications, such as steroids during the period of study drug administration
- 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
- Use of any investigational product (IP) or investigational medical device
- Any condition which could jeopardize the safety of the patient and his/her compliance in the study
Sites / Locations
- Beijing 302 Hospital of ChinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TCR-Redirected T Cells
Arm Description
HBV antigen specific TCR redirected T cells
Outcomes
Primary Outcome Measures
Safety evaluation based in Incidences of adverse events/serious adverse events
Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
Secondary Outcome Measures
Overall Response Rate
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
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.
Full Information
NCT ID
NCT03899415
First Posted
January 17, 2019
Last Updated
April 9, 2019
Sponsor
Beijing 302 Hospital
Collaborators
Lion TCR Pte. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03899415
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2019 (Anticipated)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital
Collaborators
Lion TCR Pte. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCR-Redirected T Cells
Arm Type
Experimental
Arm Description
HBV antigen specific TCR redirected T cells
Intervention Type
Biological
Intervention Name(s)
TCR redirected T cells
Intervention Description
HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10^4 - 5x10^6 TCR redirected T cells by IV infusion.
Primary Outcome Measure Information:
Title
Safety evaluation based in Incidences of adverse events/serious adverse events
Description
Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
Time Frame
Up to 1 month after the last infusion
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
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)
Title
Overall survival rate
Description
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.
Time Frame
Up to 5 years from the last infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Expression of the specific human leukocyte antigen (HLA) class I profile
Hepatocellular carcinoma (HCC) with positive test for hepatitis B virus surface antigen (HBsAg)
BCLC stage C
At least 1 month after surgical intervention or 2 weeks after TACE (may include other type of resection/ablation) No major post-operative complication
Laboratory criteria:
Liver function: Child A, ALT < 200 U/L, AST < 200 U/L, Tbil < 17.1umol/L
Renal Function: Creatinine clearance ≥ 60ml/minute
Cardiac Function: No abnormality in cardiac enzyme and ECG
Pulmonary Function (Lung): No abnormality in chest X-ray
Sexually active subjects must be willing to use an acceptable method of contraception
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:
Subject experiencing acute infection or gastric bleeding within 30 days
Mid to late stage cirrhosis, i.e. Child-Pugh Score ≥ 7
Known history of testing positive for human immunodeficiency virus (HIV)
Other liver complications, including alcoholic liver disease, non-alcoholic autoimmune liver disease, drug induced liver disease
Serious systemic conditions, such as mental illness, cerebrovascular disease, coronary heart disease, diabetes, epilepsy
Women who are pregnant or breast-feeding
History of allergic reaction to blood products or investigational products
History of chronic alcoholism or drug abuse/addiction
Require systemic medications, such as steroids during the period of study drug administration
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
Use of any investigational product (IP) or investigational medical device
Any condition which could jeopardize the safety of the patient and his/her compliance in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Shi
Phone
86-10-63879735
Email
shiming302@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fusheng Wang, MD
Organizational Affiliation
Beijing 302 Hospital of China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing 302 Hospital of China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fusheng Wang, MD
Phone
01066933328
Email
fswang302@163.com
First Name & Middle Initial & Last Name & Degree
Fusheng Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34850325
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.
Results Reference
derived
Learn more about this trial
TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
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