Hepatocellular CarcinomaLOCUSNCT06194461
LTFU for All Cell and Gene Therapy Studies
An observational study of Hepatocellular Carcinoma and Prostate Cancer, run by AstraZeneca at 25 sites in 4 countries.
Trial summary
Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Hepatocellular Carcinoma, Prostate Cancer
- What is being tested?
- AZD5851 and AZD0754
- How many people
- 64 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 17 Sep 2025to 29 Nov 2041
- Phase
- Observational
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.
Who may be able to join
- The participant has received a cell or gene therapy in another AstraZeneca protocol.
- Provision of signed and dated, written informed consent before any study-specific procedures.
Who cannot join
- Not applicable
- -
Trial locations and contacts
25 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
25 sites in 4 countries
United States18 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Columbus, Ohio, 43210
Research Site
Duarte, California, 91010
Research Site
Hackensack, New Jersey, 07601
Research Site
Houston, Texas, 77030
Research Site
Jacksonville, Florida, 32224
Research Site
New York, New York, 10065
Research Site
Orange, California, 92868
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85054
Research Site
Pittsburgh, Pennsylvania, 15237
Research Site
Portland, Oregon, 97239
Research Site
Rochester, Minnesota, 55905
Research Site
San Francisco, California, 94143
Research Site
St Louis, Missouri, 63110
Research Site
Tampa, Florida, 33612
Research Site
Washington D.C., District of Columbia, 20007
Research Site
Westwood, Kansas, 66205
Japan3 sites
Research Site
Kashiwa, 227-8577
Research Site
Kyoto, 606-8507
Research Site
Osakasayama-shi, 589-8511
South Korea3 sites
Research Site
Seoul, 03080
Research Site
Seoul, 05505
Research Site
Seoul, 06351
About this study
Official title: A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.
Read the detailed description
This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.
- Conditions
- Hepatocellular Carcinoma, Prostate Cancer
- Being tested
- AZD5851, AZD0754
- Keywords
- Cell Therapy, Gene Therapy, Long term follow up, LTFU, Hepatocellular carcinoma, Prostate cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5851Biological
Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884.
AZD0754Biological
Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.
| Study group | Role | What they receive |
|---|---|---|
| AZD5851 | Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884 Receives: Biological: AZD5851 | |
| AZD0754 | Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729 Receives: Biological: AZD0754 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of specific AEs
To determine long-term safety of previous treatment with applicable cell and gene therapy products
Measured: Maximum of 15 years post dosing
Secondary outcomes (2)
Disease progression status and Overall survival
To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product
Measured: Maximum of 15 years post dosing.
Kinetics parameters that indicate persistence (eg, Clast and Tlast)
To characterise the long-term persistence of the cell or gene therapy product.
Measured: Maximum of 15 years post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start17 Sep 2025 (estimated)
- Primary completion29 Nov 2041 (estimated)
- Study completion29 Nov 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194461
- Sponsor's protocol ID
- D9341C00001
- Acronym
- LOCUS
- Status last verified
- Jun 2025
- First submitted
- 7 Dec 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
- ClinicalTrials.gov ID
- NCT06194461
- Acronym / sponsor ID
- LOCUS / D9341C00001
- Conditions
- Hepatocellular Carcinoma, Prostate Cancer
- Keywords
- Cell Therapy, Gene Therapy, Long term follow up, LTFU, Hepatocellular carcinoma, Prostate cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (estimated)
- Primary completion
- 29 Nov 2041 (estimated)
- Study completion
- 29 Nov 2041 (estimated)
- First posted
- 8 Jan 2024 (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.
Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.
Detailed description
This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD5851 | – | Biological: AZD5851Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884 |
| AZD0754 | – | Biological: AZD0754Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.
Key inclusion criteria (2 listed)
- The participant has received a cell or gene therapy in another AstraZeneca protocol.
- Provision of signed and dated, written informed consent before any study-specific procedures.
Key exclusion criteria (2 listed)
- Not applicable
- -
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 |
|---|---|---|
| AZD5851Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884. | Biological | AZD5851 |
| AZD0754Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729. | Biological | AZD0754 |
Primary outcome
Incidence of specific AEs
Time frame: Maximum of 15 years post dosing
To determine long-term safety of previous treatment with applicable cell and gene therapy products
2 secondary outcomes
Disease progression status and Overall survival
Time frame: Maximum of 15 years post dosing.
Kinetics parameters that indicate persistence (eg, Clast and Tlast)
Time frame: Maximum of 15 years post dosing
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 27 Jun 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
AstraZeneca Clinical Study Information Center contact
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Prostate Cancer, run by AstraZeneca at 25 sites in 4 countries.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Japan, South Korea, Australia. 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.
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?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of specific AEs (time frame: Maximum of 15 years post dosing). 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 27 Jun 2025.