The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.
This comprehensive long-term follow-up study is meticulously designed to assess the safety and persistence of GF-CART01. Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are eligible to participate in this follow-up study. The study may allow for a maximum enrollment of 18 subjects.
Study Type
OBSERVATIONAL
Enrollment
18
National Taiwan University Hospital
Taipei, Taiwan
Long-Term Safety of GF-CART01 after infusion
Percentage of subjects with ≥ grade 3 GF-CART01-related adverse events, serious adverse events (SAEs), adverse events of special interest (AESIs)
Time frame: up to 15 years after GF-CART01 infusion
GF-CART01 persistence
Measure the duration of GF-CART01 presence after cell infusion * Clast * Time of Clast
Time frame: up to 15 years after GF-CART01 infusion
Efficacy of GF-CART01
Assess the overall survival (OS) up to 15 years after GF-CART01 infusion
Time frame: up to 15 years after GF-CART01 infusion
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