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

Phase 1

• Conditions: Hepatocellular Carcinoma
• Interventions: Biological: TCR redirected T cells

• Registration Number: NCT03899415
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10
• Study Start: 2019-04-20
• Primary Completion: 2022-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TCR-Redirected T Cells	TCR redirected T cells	HBV antigen specific TCR redirected T cells

Primary Outcome Measures

Name	Time	Method
Safety evaluation based in Incidences of adverse events/serious adverse events	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

Name	Time	Method
Overall survival rate	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.
Overall Response Rate	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.

Trial Locations

Locations (1)

Beijing 302 Hospital of China; 🇨🇳 Beijing, Beijing, China