CancerPhase 1/2NCT03096093
Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer
A Phase 1/2 study testing ACIT-1 in people with Cancer and Neoplasms, run by Cancer Vaccines Limited at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ACIT-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Apr 2017to Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, CH63 4JY
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP
About this study
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
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.
Read the 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.
- Being tested
- ACIT-1
- Keywords
- Pancreatic, Late stage cancer, Immunotherapy, Phase I, Vaccination
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACIT-1Biological
Cell suspension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: ACIT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Measured: From start of treatment to 20 weeks.
Secondary outcomes (1)
Clinical benefit
Survival time
Measured: From start of treatment up to 14 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start25 Apr 2017
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Vaccines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation 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
- Responsible party
- Sponsor
- Investigators
- Daniel H Palmer, MBChB PhD, Principal investigator, Clatterbridge Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096093
- Sponsor's protocol ID
- ACIT-1-1001
- Other IDs
- 2012-005426-30
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2017
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03096093
- Acronym / sponsor ID
- ACIT-1-1001
- Keywords
- Pancreatic, Late stage cancer, Immunotherapy, Phase I, Vaccination
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cancer Vaccines LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Liverpool University Hospitals NHS Foundation 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
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy - pancreatic cancer | Experimental | Biological: ACIT-1Intradermal 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 | Biological: ACIT-1Intradermal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACIT-1Cell suspension | Biological | Immunotherapy - other late stage cancers, Immunotherapy - pancreatic cancer |
Primary outcome
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.
1 secondary outcome
Clinical benefit
Time frame: From start of treatment up to 14 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel H Palmer, MBChB PhD principal investigator
Clatterbridge Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACIT-1 in people with Cancer and Neoplasms, run by Cancer Vaccines Limited at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity (time frame: From start of treatment to 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.