Data-informed optimization of CAR T-cell therapy long-term follow-up - PubMed
2 hours ago
- #CAR T-cell therapy
- #adverse events
- #long-term follow-up
- Current long-term follow-up (LTFU) requirements for CAR T-cell therapy span 15 years, posing significant challenges for patients and providers.
- Analysis of aggregated data shows adverse events (AEs) are infrequently reported after 3 years post-infusion, with secondary T-cell malignancies mainly occurring within the first 2 years.
- Based on cumulative safety data, a 5-year follow-up period may be scientifically sufficient for both clinical trials and commercial settings.
- The paper proposes a streamlined, automated data collection process using electronic health records and third-party databases to improve efficiency.
- Recommendations include feasibility testing of the updated approach on an established platform and outlining regulatory policies to facilitate adoption.