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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form which includes compliance with the requirements and restrictions listed in the willing to sign a consent form form (ICF) and in this protocol. Who Should NOT Join This Trial: There are no specific exclusion criteria for this study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

GENETIC

Pell'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