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

NCT05377307 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2025-05-13

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Pell Bio-Med Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen-Lung Lin, MD · Pell Bio-Med Technology Co., Ltd.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2036-12-31
Completion
2037-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377307 on ClinicalTrials.gov