RecruitingNCT05377307

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

Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy


Sponsor

Pell Bio-Med Technology Co., Ltd.

Enrollment

49 participants

Start Date

Dec 29, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This is a long-term safety follow-up study for patients who previously received a special type of immune cell therapy — called lentiviral-based gene-edited immune cell therapy — in a clinical trial. The goal is to monitor participants for up to 15 years to make sure the treatment remains safe over time. **You may be eligible if...** - You previously received lentiviral-based gene-edited immune cell therapy (from Pell's) as part of a clinical trial - Your last infusion of that therapy was within the past 15 years - You (or your legal guardian) are able to provide informed consent **You may NOT be eligible if...** - You have never received this specific type of gene-edited immune cell therapy - There are no other specific exclusion criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICPell's lentiviral-based gene-edited immune cell therapy

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.


Locations(5)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

Taipei Medical University - Taipei Medical University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05377307


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