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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005426-30 | EudraCT Number |
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| Name | Class |
|---|---|
| Liverpool University Hospitals NHS Foundation Trust | OTHER_GOV |
| The Clatterbridge Cancer Centre NHS Foundation Trust | OTHER |
| University of Liverpool | OTHER |
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This study evaluates four different doses of ACIT-1 for safety and for the ability to raise effective anti-cancer immune responses in patients with pancreatic and other cancers. Approximately half of the patients will have pancreatic cancer and the other half will have other cancers.
The immune system has an important role in helping prevent cancer by destroying early cancer cells. When cancer does develop antigen-specific immune (T) cells are still present in the blood but are either not responding or are not effective. Vaccines stimulate these T cells to respond and kill cancer cells.
ACIT-1 is designed to stimulate tumour antigen-specific T cells to respond and kill cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunotherapy - pancreatic cancer | Experimental | Intradermal injection of ACIT-1 cellular immunotherapy, a total of 2 doses, 4 weeks apart of either 10e5, 10e6, 10e7 or 3x10e7 cells. For patients with pancreatic or haematological cancer. Treatment will run concurrently with standard chemotherapy. |
|
| Immunotherapy - other late stage cancers | Experimental | Intradermal injection of ACIT-1 cellular immunotherapy, a total of 2 doses, 4 weeks apart of either 10e5, 10e6, 10e7 or 3x10e7 cells. For patients with other late stage cancers, not receiving any other standard treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACIT-1 | Biological | Cell suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | Toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03. | From start of treatment to 20 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical benefit | Survival time | From start of treatment up to 14 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune responses | Changes in tumour antigen specific immune responses in the blood compared to baseline | Baseline, weeks 4, 8 and 20 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel H Palmer, MBChB PhD | Clatterbridge Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Liverpool University Hospital | Liverpool | Merseyside | L7 8XP | United Kingdom | ||
| The Clatterbridge Cancer Centre NHS Foundation Trust |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Cancer Research UK |
| OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Cancer Vaccines Charitable Trust | UNKNOWN |
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| Bebington |
| Wirral |
| CH63 4JY |
| United Kingdom |