Recruiting

GM T Cell Therapy

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06798298

Conditions

Long Term Safety Following GM T Cell Therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-interventional

Study Details

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.

Conditions

Long Term Safety Following GM T Cell Therapy

Study ID

NCT06798298

Start date

Nov 10, 2025

Status verified date

Jul, 2026

Completion date

Jun 17, 2040

Anticipated

Primary completion date

Jun 17, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. 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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Non-interventional

No study drug administered. Long-term follow-up only.

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 ]
  • 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 ]
  • Date of disease progression [ Time Frame: Up to 15 years ]
  • Survival status [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • GM T cell therapy
  • Replication Competent Lentivirus (RCL)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-08.