Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pell's lentiviral-based gene-edited immune cell therapy.
- Who it may be relevant to
- Registry conditions: Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma Grade 3A. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy [Time frame: 15 years]
Secondary outcome measures (4)
- Monitor for Replication Competent of Lentivirus (RCL) [Time frame: 15 years]
- Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR) [Time frame: 15 years]
- Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry) [Time frame: 5 years]
- To assess the long-term efficacy of gene-edited immune cells [Time frame: 15 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
There are no specific exclusion criteria for this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 5 centers
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung
- National Taiwan University Hospital — Taipei
- Taipei Veterans General Hospital — Taipei
- Chi Mei Medical Center — Tainan
- Taipei Medical University - Taipei Medical University Hospital — Taipei
Identifiers
NCT: NCT05377307 · PLLV-LTFU-401