A Safety and Efficacy Long-Term Follow-up Study of Adult... | NCT06798298

Studies
A Safety and Efficacy Long-Term Follow-up Study of Adult Participants Treated With Gene Modified T Cells

NCT06798298

Sponsor

Regeneron Pharmaceuticals

Status

Recruiting

Last Update Posted

Jul 8, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Long Term Safety Following GM T Cell Therapy

Interventions

Non-interventional

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2025Actual

Primary Completion Date

Jun 17, 2040Estimated

Completion Date

Jun 17, 2040Estimated

First Submitted Date

Jan 9, 2025

First Submission Date that Met QC Criteria

Jan 28, 2025

First Posted Date

Jan 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2026

Last Update Posted Date

Jul 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Genetic: Non-interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-interventional	Genetic	No study drug administered. Long-term follow-up only.	GM T cell population

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of delayed adverse events considered at least possibly related to prior gene modified T cell therapy		Up to 15 years
Persistence of gene modified T cells		Up to 15 years
Analysis of vector integration sites		Up to 15 years
Incidence of RCL		Up to 15 years
Disease progression status	To assess long-term efficacy following treatment with gene modified T cells	Up to 15 years
Date of disease progression		Up to 15 years
Survival status		Up to 15 years

Secondary Outcomes

Measure	Description	Time Frame
Health-Related Quality of Life (HRQoL) Changes	Assessed using instruments administered in the parent treatment protocol	Up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Not applicable.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Administrator	Contact	844-734-6643		clinicaltrials@regeneron.com

Overall Officials

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tennessee Oncology	Recruiting	Nashville	Tennessee	37203	United States