CAR-T Long Term Follow Up (LTFU) Study

Summary

Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

0 to 100 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Novartis Pharmaceuticals

Last updated on ClinicalTrials.gov

October 2, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites