Clinical trial NCT03096093: Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cancer
Neoplasms
Keywords: Pancreatic
Late stage cancer
Immunotherapy
Phase I
Vaccination
Lead sponsor: Cancer Vaccines Limited
Sponsor class: INDUSTRY
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
name: The Clatterbridge Cancer Centre NHS Foundation Trust
name: University of Liverpool
name: Cancer Research UK
name: National Institute for Health Research, United Kingdom
name: Cancer Vaccines Charitable Trust
First posted: 2017-03-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Toxicity
timeFrame: From start of treatment to 20 weeks.
Secondary outcomes:
measure: Clinical benefit
timeFrame: From start of treatment up to 14 months.
Other outcomes:
measure: Immune responses
timeFrame: Baseline, weeks 4, 8 and 20
Locations:
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: Merseyside
city: Bebington
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
state: Wirral
Study officials:
affiliation: Clatterbridge Cancer Centre
name: Daniel H Palmer, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References: