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Trial registered on ANZCTR


Registration number
ACTRN12616000129482
Ethics application status
Approved
Date submitted
5/01/2016
Date registered
4/02/2016
Date last updated
13/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adoptive Immunotherapy for Liver Cancer
Scientific title
Survival after T cell receptor-redirected autologous T cell therapy against relapsed hepatitis B virus-induced hepatocellular carcinoma in a liver transplanted patient.
Secondary ID [1] 288237 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular carcinoma 297164 0
Hepatitis B virus 297165 0
Liver Transplant 297246 0
Condition category
Condition code
Cancer 297383 297383 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293525 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296934 0
Survival
Timepoint [1] 296934 0
1 year
Secondary outcome [1] 319726 0
Tumor mass will be assessed after the 4th and 8th infusions by MRI and PET scan.
Timepoint [1] 319726 0
Assessed after the 4th and 8th infusions.

Eligibility
Key inclusion criteria
Relapsed post-transplant hepatocellular carcinoma
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant psychiatric disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint(s)
Safety
Statistical methods / analysis
Nil

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7496 0
New Zealand
State/province [1] 7496 0

Funding & Sponsors
Funding source category [1] 292620 0
University
Name [1] 292620 0
Duke-Nus Medical School
Address [1] 292620 0
Duke-NUS Graduate Medical School
8 College Road, Singapore 169857
Country [1] 292620 0
Singapore
Primary sponsor type
University
Name
Duke-Nus Medical School
Address
Duke-NUS Graduate Medical School
8 College Road, Singapore 169857
Country
Singapore
Secondary sponsor category [1] 291338 0
Hospital
Name [1] 291338 0
Auckland City Hospital
Address [1] 291338 0
Private Bag 92-024, Auckland, 1142.
Country [1] 291338 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294098 0
Central Health and Disability Ethics Committee.
Ethics committee address [1] 294098 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294098 0
New Zealand
Date submitted for ethics approval [1] 294098 0
01/12/2015
Approval date [1] 294098 0
18/12/2015
Ethics approval number [1] 294098 0
15/CEN/217

Summary
Brief 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.
.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62470 0
Dr William Abbott
Address 62470 0
New Zealand Liver Transplant Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 62470 0
New Zealand
Phone 62470 0
+64275483711
Fax 62470 0
Email 62470 0
wabbott@adhb.govt.nz
Contact person for public queries
Name 62471 0
Dr William Abbott
Address 62471 0
New Zealand Liver Transplant Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 62471 0
New Zealand
Phone 62471 0
+64275483711
Fax 62471 0
Email 62471 0
wabbott@adhb.govt.nz
Contact person for scientific queries
Name 62472 0
Dr William Abbott
Address 62472 0
New Zealand Liver Transplant Unit
Auckland City Hospital
Private Bag 92024
Auckland 1142
Country 62472 0
New Zealand
Phone 62472 0
+64275483711
Fax 62472 0
Email 62472 0
wabbott@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary