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

Conditions

• Long Term Safety Following GM T Cell Therapy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Non-interventional — GENETIC
  No study drug administered. Long-term follow-up only.

Study Details

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.

Key Dates

Start date

Nov 10, 2025

Status verified

Nov 2025

Primary completion

Jun 17, 2040

Completion

Jun 17, 2040

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: 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

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 ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (1)

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