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

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ClinicalTrials.gov Identifier: NCT03899415
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Lion TCR Pte. Ltd.
Information provided by (Responsible Party):
Beijing 302 Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Biological: TCR redirected T cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TCR-Redirected T Cells Therapy in Patient With HBV Related HCC
Estimated Study Start Date : April 20, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2024

Arm Intervention/treatment
Experimental: TCR-Redirected T Cells
HBV antigen specific TCR redirected T cells
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899415


Contacts
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Contact: Ming Shi 86-10-63879735 shiming302@sina.com

Locations
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China, Beijing
Beijing 302 Hospital of China Recruiting
Beijing, Beijing, China, 100039
Contact: Fusheng Wang, MD    01066933328    fswang302@163.com   
Principal Investigator: Fusheng Wang, MD         
Sponsors and Collaborators
Beijing 302 Hospital
Lion TCR Pte. Ltd.
Investigators
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Principal Investigator: Fusheng Wang, MD Beijing 302 Hospital of China

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Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT03899415     History of Changes
Other Study ID Numbers: LTCR-HCC-3-1
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases