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Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer

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ClinicalTrials.gov Identifier: NCT03096093
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Royal Liverpool and Broadgreen University Hospitals NHS Trust
The Clatterbridge Cancer Centre NHS Foundation Trust
University of Liverpool
Cancer Research UK
National Institute for Health Research, United Kingdom
Cancer Vaccines Charitable Trust
Information provided by (Responsible Party):
Cancer Vaccines Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Neoplasms Biological: ACIT-1 Phase 1 Phase 2

Detailed Description:

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2019
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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.
Biological: ACIT-1
Cell suspension

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.
Biological: ACIT-1
Cell suspension




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical benefit [ Time Frame: From start of treatment up to 14 months. ]
    Survival time


Other Outcome Measures:
  1. Immune responses [ Time Frame: Baseline, weeks 4, 8 and 20 ]
    Changes in tumour antigen specific immune responses in the blood compared to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed malignancy
  • Life-expectancy of 3 months or greater
  • Aged 18 years or above
  • Willing and able to give written informed consent for participation in the study
  • Eastern Cooperative Oncology Group performance status of 0,1,2.
  • Absolute neutrophil count of ≥ 1 x 10e12/m3
  • Platelet count of at least 70 x 10e12/m3
  • Total bilirubin < 1.5x upper limit of normal; and aspartate transaminase/alanine transaminase (AST/ALT) < 5x upper limit of normal
  • Creatinine < 1.5x upper limit of normal and/or glomerular filtration rate (GFR) > 40ml/min
  • Female patients of child bearing potential and male patients whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  • Normal ECG measurements
  • Able (in the Investigators opinion) and willing to comply with all study requirements
  • Willing to allow his or her General Practitioner (GP) and consultant, if appropriate, to be notified of participation in the study, and for the GP and/or the National Cancer Registry to be contacted during follow up after the end of treatment.

Exclusion Criteria:

  • Concurrent use of immunosuppressive drugs, in particular systemic steroid therapy, above a threshold of 10mg per day prednisolone equivalent
  • Evidence of active infection e.g. Hepatitis B, Hepatitis C, HIV or syphilis
  • Chemotherapy, radiotherapy or biological therapy within 28 days of treatment with the exception of standard of care chemotherapy for pancreatic and haematological cancer patients
  • Participation in another investigational medicinal product trial within 28 days of treatment
  • Other vaccination within previous 4 weeks
  • Antibody treatment within previous 3 months
  • Major surgery within the 14 days preceding the screening visit
  • Scheduled elective surgery or other procedures requiring general anaesthesia during the study
  • Allogeneic graft transplantation recipient
  • Active systemic autoimmune and allergic disease
  • Pregnant or lactating females
  • Significant renal or hepatic impairment as defined by the following: Serum creatinine ≥ 1.5 x upper limit of normal and/or GFR ≤ 40 ml/min. Total bilirubin ≥ 1.5 x upper limit of normal; and AST/ALT ≥ 5 x upper limit of normal
  • Life threatening illness unrelated to the patient's cancer
  • Previous history of serious adverse allergic reaction to any medication
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Information from the National Library of Medicine

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


Contacts
Contact: Charlotte Rawcliffe +44 (0)151 794 8167 C.Rawcliffe@liverpool.ac.uk
Contact: Chloe Smith +44 (0)151 794 8834 Chloe.Smith@liverpool.ac.uk

Locations
United Kingdom
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         
Sponsors and Collaborators
Cancer Vaccines Limited
Royal Liverpool and Broadgreen University Hospitals NHS Trust
The Clatterbridge Cancer Centre NHS Foundation Trust
University of Liverpool
Cancer Research UK
National Institute for Health Research, United Kingdom
Cancer Vaccines Charitable Trust
Investigators
Principal Investigator: Daniel H Palmer, MBChB PhD Clatterbridge Cancer Centre

Responsible Party: Cancer Vaccines Limited
ClinicalTrials.gov Identifier: NCT03096093     History of Changes
Other Study ID Numbers: ACIT-1-1001
2012-005426-30 ( EudraCT Number )
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Cancer Vaccines Limited:
Pancreatic
Late stage cancer
Immunotherapy
Phase I
Vaccination

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs