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Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy

Recruitingn/aAges any - anyAllPell Bio-Med Technology Co., Ltd.
NCT05377307 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials. 2. The last lentiviral-based gene-edited immune cell infusion within 15 years. 3. Patient/patient's parent/legal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: There are no specific exclusion criteria for this study.
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What it tests

  • Pell's lentiviral-based gene-edited immune cell therapy
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Where

5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
Taipei Medical University - Taipei Medical University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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