Clinical trial NCT05377307: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Large B Cell Lymphoma
Large B-cell Lymphoma
Primary Mediastinal Large B Cell Lymphoma
Follicular Lymphoma Grade 3A
Follicular Lymphoma Grade 3B
Keywords: DLBCL(Diffuse Large B Cell Lymphoma)
PMLBCL(Primary Mediastinal Large B Cell Lymphoma)
FL(Follicular Lymphoma)
Lead sponsor: Pell Bio-Med Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all patients who have ever received Pell's lentiviral-based gene-edited immune cell therapy.

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 criteria: 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.

Primary outcomes:
measure: To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy
timeFrame: 15 years
Secondary outcomes:
measure: Monitor for Replication Competent of Lentivirus (RCL)
timeFrame: 15 years
measure: Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)
timeFrame: 15 years
measure: Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)
timeFrame: 5 years
measure: To assess the long-term efficacy of gene-edited immune cells
timeFrame: 15 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei city
country: Taiwan
facility: Taipei Medical University - Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pell Bio-Med Technology Co., Ltd.
name: Chen-Lung Lin, MD
role: STUDY_CHAIR
References: