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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03899415
• Other study ID #: LTCR-HCC-3-1
• Status: Recruiting
• Phase: Phase 1
• Start date: April 20, 2019
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2019
• Source: Beijing 302 Hospital
• Contact: Ming Shi
• Phone: 86-10-63879735
• Email: shiming302[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Beijing 302 Hospital of China	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing 302 Hospital	Lion TCR Pte. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 month after the last infusion
Secondary	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.	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)
Secondary	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.	Up to 5 years from the last infusion