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TCR-Redirected T Cells Therapy in Patient With HBV Related HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03899415
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 10, 2019
Lion TCR Pte. Ltd.
Information provided by (Responsible Party):
Beijing 302 Hospital

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 10, 2019
Estimated Study Start Date  ICMJE April 20, 2019
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Safety evaluation based in Incidences of adverse events/serious adverse events [ Time Frame: Up to 1 month after the last infusion ]
Review the safety profile of T-Cell Therapy by assessing adverse/serious adverse events reported.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Overall Response Rate [ 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) ]
    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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Official Title  ICMJE TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE Biological: 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.
Study Arms  ICMJE Experimental: TCR-Redirected T Cells
HBV antigen specific TCR redirected T cells
Intervention: Biological: TCR redirected T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ming Shi 86-10-63879735
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03899415
Other Study ID Numbers  ICMJE LTCR-HCC-3-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Beijing 302 Hospital
Study Sponsor  ICMJE Beijing 302 Hospital
Collaborators  ICMJE Lion TCR Pte. Ltd.
Investigators  ICMJE
Principal Investigator: Fusheng Wang, MD Beijing 302 Hospital of China
PRS Account Beijing 302 Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP