Long-term safety follow-up of gene-edited immune cell therapy in lymphoma patients
Follows people with lymphoma who once received gene-edited immune cell therapy.
Plain-language title generated from the registry record
Registry title: Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
Key facts
- Where
- Kaohsiung, Tainan, and Taipei, TaiwanSee the 5 sites
Where in Taiwan
- Kaohsiung Medical University Chung-Ho Memorial HospitalKaohsiung, TaiwanTaking people
- Chi Mei Medical CenterTainan, TaiwanTaking people
- National Taiwan University HospitalTaipei, TaiwanTaking people
- Taipei Medical University - Taipei Medical University HospitalTaipei, TaiwanTaking people
- Taipei Veterans General HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pell Bio-Med Technology Co., Ltd.
- Trial code
- NCT05377307
- Record updated
- 9 October 2026
- Original description
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.Read full original descriptionShow less
Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
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.
Inclusion: Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials; The last lentiviral-based gene-edited immune cell infusion within 15 years; 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: There are no specific exclusion criteria for this study.