Actively Recruiting

All Genders
NCT05377307

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

Led by Pell Bio-Med Technology Co., Ltd. · Updated on 2025-05-13

49

Participants Needed

5

Research Sites

778 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or combination therapy in clinical trials
  • The last lentiviral-based gene-edited immune cell infusion must have been within 15 years
  • Patient or patient's parent/legal guardian must be able to give signed informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • There are no specific exclusion criteria for this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, Taiwan, 807377

Actively Recruiting

2

National Taiwan University Hospital

Taipei, Taiwan, Taiwan, 10025

Actively Recruiting

3

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan, 112201

Actively Recruiting

4

Chi Mei Medical Center

Tainan, Taiwan, 710

Actively Recruiting

5

Taipei Medical University - Taipei Medical University Hospital

Taipei, Taiwan, 11031

Actively Recruiting

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Research Team

C

Cherry Lo, MSC

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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