Spots Global Cancer Trial Database for Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
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Trial Identification
Brief Title: Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
Official Title: Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
Study ID: NCT05377307
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Taipei Medical University - Taipei Medical University Hospital, Taipei city, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Chen-Lung Lin, MD
Affiliation: Pell Bio-Med Technology Co., Ltd.
Role: STUDY_CHAIR
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