General Information |
| Summary |
This clinical study is looking at a vaccine called AST-VAC2 in adult patients with advanced non-small cell lung cancer (NSCLC). The main aim of the study: If the dose can be given safely to patients, learn more about the potential side effects of the vaccine and how they can be managed and also what happens to AST-VAC2 inside the body (looking for effects in the blood, skin or tumour). |
| Description |
This clinical study is looking at a vaccine called AST-VAC2. AST-VAC2 has been designed to potentially help the immune system attack the cancer. This is a new vaccine which looks promising in laboratory studies but it has never been tested in man.
Dendritic cells occur naturally in your body as part of the immune system however these dendritic cells have a special role in finding proteins in the body which are associated with cancer and it is hoped that the vaccine will train the immune system to recognise these proteins and attack the cancer.
Some cancers tend to have more of a certain type of protein (part of the body's building blocks that make up cells) called 'hTERT' and it has been shown in laboratory studies (and also studies in patients using a similar type of vaccine), that targeting hTERT can lead to destruction of cancer cells by the immune system. AST-VAC2 will target the hTERT protein.
Human Leukocyte Antigen (HLA) is another type of protein. An HLA pre-screening test will be able to show if a person is positive or negative for a specific HLA protein (AST-VAC2 can only work with some types of HLA), as being positive for the protein may mean there is a better chance of the vaccine attacking the cancer. Patients who are positive for the specific HLA type will be asked to consent to the vaccine. Those patients who are negative for the HLA type will not be eligible for the trial. |
| Clinical trials phase |
Phase 1 |
| Start date (estimated) |
2018-06-01 |
| End date (estimated) |
2027-02-22 |
| Clinical feature |
| Label |
lung non-small cell carcinoma |
| Link |
http://purl.obolibrary.org/obo/DOID_3908 |
| Description |
A lung carcinoma that is characterized as any type of epithelial lung cancer other than small cell lung carcinoma. |
|
Administrative Information |
| NCT number |
NCT03371485 |
| ICTRP weblink |
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03371485 |
| EudraCT number |
2016-002577-35 |
| Other study identifiers |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT03371485 |
| Public contact |
| Email |
j.anderson@ucl.ac.uk |
| First name |
John |
| Last name |
Anderson |
|
| Sponsors |
Cancer Research UK
|
Cells |
| Source pluripotent stem cell lines |
|
| Which differentiated cell type is used |
| Label |
dendritic cell, human |
| Link |
http://purl.obolibrary.org/obo/CL_0001056 |
| Description |
A dendritic cell with the phenotype HLA-DRA-positive.; This cell type is compatible with the HIPC Lyoplate markers for 'dendritic cell'. The inclusion of HLA-DRA in the definition restricts this definition to human dendritic cells. |
|
Recruitment |
| Recruitment Status |
Active, not recruiting |
| Estimated number of participants |
8 |
