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According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.
After completion or early withdraw from the other treatment protocol, patients should be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | After completion or early withdraw from the treatment protocol, patients will be enrolled into this long-term follow-up study. If patients do not enter this study right after leaving the treatment protocol, they may have the option to enter this study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion. |
| |
| Group B | Some patients may require joining other Pell's gene-edited immune cell therapy study during participating in this long-term follow-up study. For such case, the patient could be enrolled into the new treatment protocol. Meanwhile, the patient can be remaining in this long-term follow-up protocol as an inactive participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pell's lentiviral-based gene-edited immune cell therapy | Genetic | No study drug or other planned treatment will be administered. Subjects who previously received Pell's lentiviral-based gene-edited immune cell therapy will be evaluated the safety and efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy | • Proportion of patients with any events of the following items which are suspected related to previous gene-edited immune cell therapy.
| 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor for Replication Competent of Lentivirus (RCL) | Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR | 15 years |
| Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR) |
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Inclusion Criteria:
Exclusion Criteria:
There are no specific exclusion criteria for this study.
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The study population includes all patients who have ever received Pell's lentiviral-based gene-edited immune cell therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cherry Lo, MSC | Contact | 886-2-8791-1789 | 3111 | cherry.lo@pellbmt.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen-Lung Lin, MD | Pell Bio-Med Technology Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung | Taiwan | 807377 | Taiwan |
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Blood Samples
Proportion of patients with detectable transgene level in peripheral blood by qPCR |
| 15 years |
| Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry) | Persistence of gene-edited immune cells in peripheral blood using flow cytometry | 5 years |
| To assess the long-term efficacy of gene-edited immune cells |
| 15 years |
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan | 10025 | Taiwan |
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| Taipei Veterans General Hospital | Recruiting | Taipei | Taiwan | 112201 | Taiwan |
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| Chi Mei Medical Center | Recruiting | Tainan | 710 | Taiwan |
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| Taipei Medical University - Taipei Medical University Hospital | Recruiting | Taipei | 11031 | Taiwan |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
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