CAR T CellLTFU-01NCT07424157
Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products
An observational study of CAR T Cell and CAR T Cell Therapy, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CAR T Cell, CAR T Cell Therapy
- What is being tested?
- Long term follow up in all patients who received an SCTx gene therapy product
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 31 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have received treatment with a gene therapy product on an SCTx Sponsored clinical trial.
Who may be able to join
- Enrolled in an SCTx GTP clinical trial;
- Received or planned to receive an SCTx GTP;
- Subject and/or legally authorized representative have provided consent/assent for study participation.
Who cannot join
None listed.
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
Seattle Children's Hospital
Seattle, Washington, 98105
Adam Lamble, 206-987-2106, CBDCIntake@seattlechildrens.org
About this study
Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.
- Conditions
- CAR T Cell, CAR T Cell Therapy
- Being tested
- Long term follow up in all patients who received an SCTx gene therapy product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term follow up in all patients who received an SCTx gene therapy productOther
Participants will be followed for 15 years following the receipt of their final infusion on a separate SCTx gene therapy protocol to monitor for the long term effects of CAR T cell therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed adverse events
The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.
Measured: 15 years post-final infusion of SCTx GTP
Long-term persistence of SCTx Gene Therapy Products
Monitor for long-term persistence of SCTx GTPs.
Measured: 15 years post-final infusion
Long-term clinical outcomes following treatment with SCTx GTP
Death from any cause and first relapse following an initial remission
Measured: 15 years post-final infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Jun 2026
- Primary completion31 Mar 2041 (estimated)
- Study completion31 Mar 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR T CellStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Annesley, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424157
- Sponsor's protocol ID
- LTFU-01
- Acronym
- LTFU-01
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up of Subjects Treated With Seattle Children's Therapeutics Gene Therapy Products
- ClinicalTrials.gov ID
- NCT07424157
- Acronym / sponsor ID
- LTFU-01 / LTFU-01
- Conditions
- CAR T Cell, CAR T Cell Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 31 Mar 2041 (estimated)
- Study completion
- 31 Mar 2041 (estimated)
- First posted
- 20 Feb 2026 (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.
Subjects exposed to gene therapy products (GTPs) may be at risk for delayed or long-term adverse events. This is a long-term follow-up (LTFU) protocol designed to evaluate the long-term safety of Seattle Children's Therapeutics (SCTx) GTPs and incorporates in monitoring guidance from the U.S. Food and Drug Administration (FDA). Subjects will be followed for up to 15 years starting from the date of the most recent infusion of an SCTx GTP. Subjects planning to receive, or who have received, at least one infusion of an SCTx GTP will be offered participation in this LTFU study. Subjects enrolled in this study will have safety assessments and laboratory evaluations performed at scheduled intervals for each unique SCTx GTP received. No treatment is administered in this LTFU study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have received treatment with a gene therapy product on an SCTx Sponsored clinical trial.
Key inclusion criteria (3 listed)
- Enrolled in an SCTx GTP clinical trial;
- Received or planned to receive an SCTx GTP;
- Subject and/or legally authorized representative have provided consent/assent for study participation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Long term follow up in all patients who received an SCTx gene therapy productParticipants will be followed for 15 years following the receipt of their final infusion on a separate SCTx gene therapy protocol to monitor for the long term effects of CAR T cell therapy | Other | – |
Primary outcome
Incidence of delayed adverse events
Time frame: 15 years post-final infusion of SCTx GTP
The type, frequency, severity, and duration of adverse events considered related to the SCTx gene therapy product (GTP) the participant received.
Long-term persistence of SCTx Gene Therapy Products
Time frame: 15 years post-final infusion
Monitor for long-term persistence of SCTx GTPs.
Long-term clinical outcomes following treatment with SCTx GTP
Time frame: 15 years post-final infusion
Death from any cause and first relapse following an initial remission
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 25 Jun 2026.
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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.
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 CAR T Cell and CAR T Cell Therapy, run by Seattle Children's Hospital 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 0 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 25 Jun 2026. 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 Adam Lamble (206-987-2106, CBDCIntake@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed adverse events (time frame: 15 years post-final infusion of SCTx GTP). The study lists 3 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 25 Jun 2026.