Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells

Condition(s) studied

Investigational drug(s) / intervention(s)

AUTO CAR T cell therapy: No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.

Study summary

Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.

Eligibility

Primary outcome measure(s)

• Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy — For up to 15 years
  Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.

Trial sites (8)

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