Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03096093|
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : May 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Neoplasms||Biological: ACIT-1||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Study to Determine the Optimal Dose for the Safe Immune Restoration and Immune Response of Allogeneic Cell Immunotherapy (ACIT-1) in Adult Cancer Patients|
|Actual Study Start Date :||April 25, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: Immunotherapy - pancreatic cancer
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.
Experimental: Immunotherapy - other late stage cancers
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.
- Toxicity [ Time Frame: From start of treatment to 20 weeks. ]Toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
- Clinical benefit [ Time Frame: From start of treatment up to 14 months. ]Survival time
- Immune responses [ Time Frame: Baseline, weeks 4, 8 and 20 ]Changes in tumour antigen specific immune responses in the blood compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096093
|Contact: Charlotte Rawcliffe||+44 (0)151 794 8167||C.Rawcliffe@liverpool.ac.uk|
|Contact: Sara Martin||+44 (0)151 794 8333||Sara.Harrison@liverpool.ac.uk|
|Royal Liverpool University Hospital||Active, not recruiting|
|Liverpool, Merseyside, United Kingdom, L7 8XP|
|The Clatterbridge Cancer Centre NHS Foundation Trust||Recruiting|
|Bebington, Wirral, United Kingdom, CH63 4JY|
|Principal Investigator: Daniel H Palmer, MBChB PhD|
|Principal Investigator:||Daniel H Palmer, MBChB PhD||Clatterbridge Cancer Centre|