Long Term Safety Following GM T Cell TherapyNCT06798298
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells
An observational study of Long Term Safety Following GM T Cell Therapy, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
This is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Safety Following GM T Cell Therapy
- What is being tested?
- Non-interventional
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to 17 Jun 2040
- 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: Enrolled participants will be determined by the number of participants participating in GM T cell 2seventy bio (prior to April 2024) and Regeneron Pharmaceuticals sponsored studies consenting to participate in the LTFU study.
Who may be able to join
- All participants who received at least one GM T cell infusion in a previous 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study, and have completed the post-treatment follow-up period on the parent treatment protocol, or discontinued follow-up on the parent protocol after completing at least 6 months of safety monitoring, as applicable.
- Participant (and legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study related assessments/procedures being conducted.
Who cannot join
- Not applicable.
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
Tennessee Oncology
Nashville, Tennessee, 37203
About this study
Official title: A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
This is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products.
Participants who received at least one infusion of gene modified T cells in a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study will be asked to participate in this LTFU protocol, upon either premature discontinuation from, or completion of the parent treatment protocol.
Participants enrolled in this LTFU protocol will have safety assessments, laboratory evaluations, and complete patient-reported outcome (PRO) questionnaires at scheduled intervals as applicable.
- Being tested
- Non-interventional
- Keywords
- GM T cell therapy, Replication Competent Lentivirus (RCL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalGenetic
No study drug administered. Long-term follow-up only.
| Study group | Role | What they receive |
|---|---|---|
| GM T cell population | Participants exposed to gene modified T cell therapy on a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study Receives: Genetic: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
Measured: Up to 15 years
Persistence of gene modified T cells
Measured: Up to 15 years
Analysis of vector integration sites
Measured: Up to 15 years
Incidence of RCL
Measured: Up to 15 years
Disease progression status
To assess long-term efficacy following treatment with gene modified T cells
Measured: Up to 15 years
Date of disease progression
Measured: Up to 15 years
Survival status
Measured: Up to 15 years
Secondary outcomes (1)
Health-Related Quality of Life (HRQoL) Changes
Assessed using instruments administered in the parent treatment protocol
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start10 Nov 2025
- Primary completion17 Jun 2040 (estimated)
- Study completion17 Jun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Safety Following GM T Cell TherapyStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798298
- Sponsor's protocol ID
- LTF-01
- Status last verified
- Jul 2026
- First submitted
- 9 Jan 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Follow-up Protocol for Participants Treated With Gene Modified T Cells
- ClinicalTrials.gov ID
- NCT06798298
- Acronym / sponsor ID
- LTF-01
- Keywords
- GM T cell therapy, Replication Competent Lentivirus (RCL)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 17 Jun 2040 (estimated)
- Study completion
- 17 Jun 2040 (estimated)
- First posted
- 29 Jan 2025 (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 is a prospective study for the Long-Term Follow-Up (LTFU) of safety and efficacy of all participants exposed to gene modified (GM) T cell therapy in accordance with Health Authorities' guidance for participants treated with gene therapy products.
Participants who received at least one infusion of gene modified T cells in a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study will be asked to participate in this LTFU protocol, upon either premature discontinuation from, or completion of the parent treatment protocol.
Participants enrolled in this LTFU protocol will have safety assessments, laboratory evaluations, and complete patient-reported outcome (PRO) questionnaires at scheduled intervals as applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GM T cell population | – | Genetic: Non-interventionalParticipants exposed to gene modified T cell therapy on a 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled participants will be determined by the number of participants participating in GM T cell 2seventy bio (prior to April 2024) and Regeneron Pharmaceuticals sponsored studies consenting to participate in the LTFU study.
Key inclusion criteria (2 listed)
- All participants who received at least one GM T cell infusion in a previous 2seventy bio (prior to April 2024) or Regeneron Pharmaceuticals sponsored study, and have completed the post-treatment follow-up period on the parent treatment protocol, or discontinued follow-up on the parent protocol after completing at least 6 months of safety monitoring, as applicable.
- Participant (and legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study related assessments/procedures being conducted.
Key exclusion criteria (1 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 |
|---|---|---|
| Non-interventionalNo study drug administered. Long-term follow-up only. | Genetic | GM T cell population |
Primary outcome
Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy
Time frame: Up to 15 years
Persistence of gene modified T cells
Time frame: Up to 15 years
Analysis of vector integration sites
Time frame: Up to 15 years
Incidence of RCL
Time frame: Up to 15 years
Disease progression status
Time frame: Up to 15 years
To assess long-term efficacy following treatment with gene modified T cells
Date of disease progression
Time frame: Up to 15 years
Survival status
Time frame: Up to 15 years
1 secondary outcome
Health-Related Quality of Life (HRQoL) Changes
Time frame: Up to 5 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 8 Jul 2026.
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 Long Term Safety Following GM T Cell Therapy, run by Regeneron Pharmaceuticals 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 2 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 8 Jul 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 Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), 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 considered at least possibly related to prior gene modified T cell therapy (time frame: Up to 15 years). The study lists 7 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 8 Jul 2026.