Assess the long-term safety of RNA cell therapy. Assess the durability of clinical benefit of RNA cell therapy.
LTF Decartes
Long-term Follow-up of Autologous RNA Cell Therapy Recipients
All genders
18+
Recruiting now
Overview
Principal Investigator: Mithila Vullaganti, MD
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Mithila Vullaganti, MD
Study details
Inclusion Criteria
- Patient who received at least one infusion of autologous RNA cell therapy developed by Cartesian (e.g. Descartes-08, Descartes-11, or Descartes-15) at any dose level, in a clinical trial or expanded access setting;
- Patient must be willing and able to complete all study visits
- Patient must be willing and able to provide informed consent in writing or via telephone.
Exclusion Criteria
- Patient is actively enrolled in an interventional autologous RNA cell therapy trial or expanded access program;
Patient is not fit to take part in a clinical study, in the opinion of the investigator- Last autologous RNA cell therapy infusion is > 3 years from the screening visit
Study Requirements
During the 5-year follow-up period, patients will be contacted twice a year (every 6 months ± 4 weeks) via telephone, video call, or other institution-approved method of communication and site staff will review a yearly questionnaire to elicit information regarding medical history, concomitant medications, any hospitalizations, and adverse events.