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

Last updated: May 7, 2025
Sponsor: Pell Bio-Med Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Follicular Lymphoma

Lymphoma, B-cell

Lymphoma

Treatment

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

Clinical Study ID

NCT05377307
PLLV-LTFU-401
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell asmonotherapy 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 consentwhich includes compliance with the requirements and restrictions listed in theinformed consent form (ICF) and in this protocol.

Exclusion

Exclusion Criteria:

There are no specific exclusion criteria for this study.

Study Design

Total Participants: 49
Treatment Group(s): 1
Primary Treatment: Pell's lentiviral-based gene-edited immune cell therapy
Phase:
Study Start date:
December 29, 2022
Estimated Completion Date:
December 31, 2037

Study 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.

Connect with a study center

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807377
    Taiwan

    Active - Recruiting

  • Chi Mei Medical Center

    Tainan City, 710
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10025
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112201
    Taiwan

    Active - Recruiting

  • Taipei Medical University - Taipei Medical University Hospital

    Taipei city, 11031
    Taiwan

    Active - Recruiting

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