A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation

L

Lion TCR

Status and phase

Completed
Phase 1

Conditions

Hepatocellular Carcinoma

Treatments

Biological: No intervention and TCR-T (at crossover)
Biological: TCR-T

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02686372
LTCR-HCC-1-1

Details and patient eligibility

About

Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population.

Full description

A open-label, cohort clinical study of T cell receptor-redirected T cells to prevent recurrence of HBV-related hepatocellular carcinoma after liver transplantation. Subjects will be enrolled into the observation cohort or treatment cohort. Subjects enrolled in the treatment group will receive escalating doses of HBV/ TCR expressing autologous T cells after confirming eligibility. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse. Upon disease recurrence, eligible patient may receive HBV specific T-cell receptor (TCR-T) treatment.

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis as hepatocellular carcinoma (HCC)
  • Underwent liver transplantation
  • Seropositive for hepatitis B surface antigen (HBsAg), or presence of HBV DNA or HBV RNA before liver transplantation
  • Expression of TCR-T target epitopes within specific human leukocyte antigen (HLA) class I profile
  • No major post-operative complication
  • Life expectancy of at least 3 months
  • Ability to provide informed consent
  • Ability to comply with study procedures

Exclusion criteria

  • Known, clinically suspected or has history or central nervous system (CNS) and bone metastasis
  • Significant ongoing immunologic rejection based on pathology and clinical diagnosis
  • Evidence or history of significant bleeding diathesis or coagulopathy
  • Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
  • Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • Women who are pregnant or breast-feeding
  • Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

13 participants in 2 patient groups

HBV/TCR-T cell infusion
Experimental group
Description:
Subjects enrolled in the experimental (treatment) group will receive escalating doses of HBV/ TCR expressing autologous T cells. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse.
Treatment:
Biological: TCR-T
No intervention and TCR-T (at crossover)
Other group
Description:
No intervention and to be crossover to experimental arm upon confirmation of disease recurrence.
Treatment:
Biological: No intervention and TCR-T (at crossover)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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