AFPc332T Cell Therapy in Advanced Hepatocellular Carcinoma (HCC)
Research type
Research Study
Full title
A Phase I Open Label, Clinical Trial Evaluating the Safety and Anti-tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha-fetoprotein (AFPc332T) in HLA-A2 Positive Subjects with Advanced Hepatocellular Carcinoma (HCC)
IRAS ID
223213
Contact name
Tim Meyer
Contact email
Sponsor organisation
Adaptimmune LLC
Eudract number
2017-000778-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Hepatocellular carcinoma (Liver cancer or HCC for short) accounted for an estimated 782,000 new cases worldwide in 2012. Behind lung cancer, it is the second highest cause of cancer-related death globally.
The diagnosis of HCC can often be challenging and disease that is diagnosed at an advanced stage, or disease that has progressed after therapy, has a poor prognosis due to the lack of effective treatment options.
Immunotherapy is a type of therapy which uses the patient’s immune system to fight their cancer. Central to the body's immune system is a type of blood cell, known as a T-cell. T-cells collected from the patient's blood can be genetically modified in order to potentially enhance their ability to attack the patient's cancer cells.
In this study the modified T-cells are known as AFPc332T - the investigational drug. The study will assess safety and efficacy of AFPc332T in certain patients with advanced HCC.
Summary:
Screening - patients must test positive for particular genes in their blood, have a tumour which tests positive for Alpha-fetoprotein (AFP)and have low to negative AFP in non-tumour liver tissue.Suitable patients undergo further screening.
Eligible patients undergo T-cell collection from their blood (4-5 hrs).
The T-cells are then genetically modified in the laboratory to produce the investigational drug, AFPc332T. This process takes around 4 weeks.
Three days of chemotherapy are required prepare the body to receive AFPc332T cells back into the patient's bloodstream.
After the T cell infusion, patients are hospitalised for one week for observation and after that patients are monitored under the follow-up schedule.
Monitoring continues until the patient leaves the study or their cancer worsens.
The patient will be followed-up for up to 15 years for ongoing safety review.Up to 30 adult patients will be enrolled.
Current poor prognosis, coupled with emerging results within immunotherapy arena,
provide a rationale for applying immunotherapy strategies to HCC.REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1019
Date of REC Opinion
15 Sep 2017
REC opinion
Further Information Favourable Opinion