Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical StudyNCT05822427
Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
An observational study of Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study, run by Imugene Limited at 1 site in United States.
Trial summary
The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to Dec 2039
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.
Who may be able to join
- Receipt of at least 1 dose of azer-cel in an Imugene clinical study.
- A signed informed consent form (ICF).
- Willingness and ability to adhere to the study schedule and all other protocol requirements.
Who cannot join
- No unique exclusion criteria apply to this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Science 37, Inc.
Culver City, California, 90230
About this study
The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:
- What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
- What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?
Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.
Read the detailed description
This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in an Imugene clinical study for subjects who received azer-cel. This study protocol does not include administration of azer-cel; however, subjects may receive standard of care treatment or investigational products other than azer-cel through participation in other clinical studies during the period of this observational study.
- Keywords
- Allogeneic chimeric antigen receptor (CAR) T cell products, azer-cel
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Clinically Significant Clinical Events of Interest (CEI)
Measured: Up to 15 years
Severity of Clinically Significant CEI
Measured: Up to 15 years
Duration of Clinically Significant CEI
Measured: Up to 15 years
Outcome of Clinically Significant CEI
Measured: Up to 15 years
Secondary outcomes (3)
Duration of Disease Response
Measured: Up to 15 years
Overall Survival Rate
Measured: Up to 15 years
Azer-cel Persistence
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start25 Aug 2020
- Primary completionDec 2039 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical StudyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imugene Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822427
- Sponsor's protocol ID
- PBCAR-LTF
- Status last verified
- May 2025
- First submitted
- 10 Apr 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
- ClinicalTrials.gov ID
- NCT05822427
- Acronym / sponsor ID
- PBCAR-LTF
- Keywords
- Allogeneic chimeric antigen receptor (CAR) T cell products, azer-cel
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Imugene LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Dec 2039 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 20 Apr 2023 (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.
The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:
- What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
- What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?
Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.
Detailed description
This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in an Imugene clinical study for subjects who received azer-cel. This study protocol does not include administration of azer-cel; however, subjects may receive standard of care treatment or investigational products other than azer-cel through participation in other clinical studies during the period of this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.
Key inclusion criteria (3 listed)
- Receipt of at least 1 dose of azer-cel in an Imugene clinical study.
- A signed informed consent form (ICF).
- Willingness and ability to adhere to the study schedule and all other protocol requirements.
Key exclusion criteria (1 listed)
- No unique exclusion criteria apply to this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Clinically Significant Clinical Events of Interest (CEI)
Time frame: Up to 15 years
Severity of Clinically Significant CEI
Time frame: Up to 15 years
Duration of Clinically Significant CEI
Time frame: Up to 15 years
Outcome of Clinically Significant CEI
Time frame: Up to 15 years
3 secondary outcomes
Duration of Disease Response
Time frame: Up to 15 years
Overall Survival Rate
Time frame: Up to 15 years
Azer-cel Persistence
Time frame: Up to 15 years
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study, run by Imugene Limited at 1 site in United States.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 Clinical Imugene Limited (1 984 245 0082, info@imugene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Clinically Significant Clinical Events of Interest (CEI) (time frame: Up to 15 years). The study lists 4 primary outcomes in all. 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 14 May 2025.