Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
Recruiting now
Conditions studied: Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma Grade 3A, Follicular Lymphoma Grade 3B
In brief
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.
Key facts
- Study ID
- NCT05377307
- Run by
- Pell Bio-Med Technology Co., Ltd.
- People needed
- 49
- Starts
- 2022-12-29
- Expected to finish
- 2037-12-01
- Last updated by the study team
- 2025-05-13
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- There are no specific exclusion criteria for this study.
Where it is running
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung, Taiwan, Taiwan (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan, Taiwan (enrolling)
- Taipei Veterans General Hospital — Taipei, Taiwan, Taiwan (enrolling)
- Chi Mei Medical Center — Tainan, Taiwan (enrolling)
- Taipei Medical University - Taipei Medical University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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