Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05377307

Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diffuse Large B Cell Lymphoma Dendritic Cell Sarcoma, Interdigitating Follicular Lymphoma Grade 3A Follicular Lymphoma Grade 3B Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Large B-cell Lymphoma Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Primary Mediastinal Large B Cell Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pell's lentiviral-based gene-edited immune cell therapy

Genetic

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 outcomes

  1. To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy

    Time frame: 15 years

    • 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

Secondary outcomes

  1. Monitor for Replication Competent of Lentivirus (RCL)

    Time frame: 15 years

    Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR

  2. Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)

    Time frame: 15 years

    Proportion of patients with detectable transgene level in peripheral blood by qPCR

  3. Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)

    Time frame: 5 years

    Persistence of gene-edited immune cells in peripheral blood using flow cytometry

  4. To assess the long-term efficacy of gene-edited immune cells

    Time frame: 15 years

    • Proportion of patients with relapse or progress among patients who didn't progress or relapse at study entry/reentry
    • Incidence of death

Study contacts

Contact information is provided by the study sponsor or research team.

Cherry Lo, MSC

CONTACT

[email protected]

886-2-8791-1789 ext. 3111

Sponsors and collaborators

Lead sponsor

Pell Bio-Med Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2036
Study completion
2037
First posted
May 17, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.