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

NCT03096093 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: ACIT-1-10012012-005426-30
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Neoplasms

Keywords

Pancreatic; Late stage cancer; Immunotherapy; Phase I; Vaccination

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Clinical benefit

  From start of treatment up to 14 months.

Other Outcomes (1)

• Immune responses

  Baseline, weeks 4, 8 and 20

Study Arms (2)

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.

Biological: ACIT-1

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.

Biological: ACIT-1

Interventions

ACIT-1 BIOLOGICAL

Cell suspension

Immunotherapy - other late stage cancers; Immunotherapy - pancreatic cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Vaccines Limited: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator
• University of Liverpool: collaborator
• Cancer Research UK: collaborator
• Cancer Vaccines Charitable Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• The Clatterbridge Cancer Centre NHS Foundation Trust: collaborator

Study Sites (2)

Royal Liverpool University Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, CH63 4JY, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Daniel H Palmer, MBChB PhD

  Clatterbridge Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 30, 2017
• Study Start: April 25, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)