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.
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.
None
The study population includes all patients who have ever received Pell's lentiviral-based gene-edited immune cell therapy.
Cohort
Prospective
Pell's lentiviral-based gene-edited immune cell therapy
GeneticNo 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.
To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy
• Proportion of patients with any events of the following items which are suspected related to previous gene-edited immune cell therapy. 1. New malignancies 2. New incidence or exacerbation of a pre-existing neurologic disorder 3. New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder 4. New incidence of a hematologic disorder, including hypogammaglobulinemia 5. New incidence of infection (potentially product-related) 6. Other than the above adverse events, which are suspected related to gene-edited immune cell therapy judged by the investigator
Monitor for Replication Competent of Lentivirus (RCL)
Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR
Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)
Proportion of patients with detectable transgene level in peripheral blood by qPCR
Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)
Persistence of gene-edited immune cells in peripheral blood using flow cytometry
To assess the long-term efficacy of gene-edited immune cells
1. Proportion of patients with relapse or progress among patients who didn't progress or relapse at study entry/reentry 2. Incidence of death
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