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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTFU | Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are invited to participate in this follow-up study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 15 years after GF-CART01 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| GF-CART01 persistence | Measure the duration of GF-CART01 presence after cell infusion
| 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 |
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Inclusion Criteria:
Exclusion Criteria: None
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
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whole blood
| up to 15 years after GF-CART01 infusion |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |