CompletedEarly Phase 1ACTRN12616000129482

Adoptive Immunotherapy for Liver Cancer

Survival after T cell receptor-redirected autologous T cell therapy against relapsed hepatitis B virus-induced hepatocellular carcinoma in a liver transplanted patient.

Sponsor

Duke-Nus Medical School

Enrollment

1 participants

Start Date

Jan 5, 2016

Study Type

Interventional

Conditions

Liver Transplant

Summary

This protocol describes the production of autologous, ex vivo-activated, Hepatitis B Virus (HBV) envelope gene specific, T cell receptor (TCR) redirected-T lymphocytes for re-infusion into a patient with HBV-induced hepatocellular carcinoma (HCC) that has relapsed following liver transplantation. Using current protocols, this patient can now only be offered palliative therapy. An immunological therapy based on adoptive transfer of HBV-specific T cells targeting HBV expressing HCC cells can potentially kill tumor cells while sparing normal tissue. The ability of T cells to specifically recognize cancer cells expressing specific antigens has been the basis of immunlogical therapies with TCR-modified T cells that have been successful in malignancies such as B cell lymphoma (N Engl J Med 2011;365:725-733) and melanoma (Science 2015;348:62-68). Here we propose to treat a patient with a relapse of HBV-induced HCC with T cells that have been engineered to express an envelope gene-specific TCR. These TCR-redirected T cells should exclusively recognize the HCC but not normal liver hepatocytes. .

Eligibility

Sex: Both males and femalesMin Age: 21 Yearss

Inclusion Criteria1

Relapsed post-transplant hepatocellular carcinoma

Exclusion Criteria1

Significant psychiatric disease.

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Interventions

8 infusions at 7 day intervals of increasing doses of 10,000 (1 infusion), 100,000 (1 infusion), 1,000,000 (1 infusion) and 5,000,000 (5 infusions) cells /kg of autologous t cell receptor-redirected

8 infusions at 7 day intervals of increasing doses of 10,000 (1 infusion), 100,000 (1 infusion), 1,000,000 (1 infusion) and 5,000,000 (5 infusions) cells /kg of autologous t cell receptor-redirected T cells that recognise a hepatitis B virus envelope peptide (FLGPLLVLQA) presented by HLA-Cw*0801. The cells will be prepared in the New Zealand Liver Transplant Research laboratory at Auckland City Hospital and administered by IV infusion by nursing staff.