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

Beijing 302 Hospital

Status and phase: Enrolling; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Biological: TCR redirected T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03899415

LTCR-HCC-3-1

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

TCR-Redirected T Cells

Experimental group

Description:

HBV antigen specific TCR redirected T cells

Treatment:

Biological: TCR redirected T cells