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

Regeneron Pharmaceuticals

Status

Enrolling

Conditions

Long Term Safety Following GM T Cell Therapy

Treatments

Genetic: Non-interventional

Study type

Observational

Funder types

Industry

Identifiers

NCT06798298

LTF-01

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.