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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05377307
Other study ID # PLLV-LTFU-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 29, 2022
Est. completion date December 2037

Study information

Verified date April 2024
Source Pell Bio-Med Technology Co., Ltd.
Contact Cherry Lo, MSC
Phone 886-2-8791-1789
Email cherry.lo@pellbmt.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 49
Est. completion date December 2037
Est. primary completion date December 2037
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

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

Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Taipei Medical University - Taipei Medical University Hospital Taipei city

Sponsors (1)

Lead Sponsor Collaborator
Pell Bio-Med Technology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
New malignancies
New incidence or exacerbation of a pre-existing neurologic disorder
New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
New incidence of a hematologic disorder, including hypogammaglobulinemia
New incidence of infection (potentially product-related)
Other than the above adverse events, which are suspected related to gene-edited immune cell therapy judged by the investigator
15 years
Secondary Monitor for Replication Competent of Lentivirus (RCL) Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR 15 years
Secondary 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 15 years
Secondary 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 5 years
Secondary To assess the long-term efficacy of gene-edited immune cells Proportion of patients with relapse or progress among patients who didn't progress or relapse at study entry/reentry
Incidence of death
15 years
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