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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Dec 29, 2022 to Mar 31, 2023 Interventions: Pell's lentiviral-based gene-edited immune cell therapy (Genetic) to Pell's lentiviral-based gene-edited immune cell therapy (Genetic) · Secondary endpoints: details revised at 1 of 4 entries · Site contacts updated at 2 of 5 sites · 1 more Show 4 more changesShow less
    • Interventions: Pell's lentiviral-based gene-edited immune cell therapy (Genetic) to Pell's lentiviral-based gene-edited immune cell therapy (Genetic)
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site contacts updated at 2 of 5 sites
    • Eligibility criteria expanded, about 3 words
  2. Study sites: 4 to 5 Primary completion date: Dec 2037 to Dec 2036v6 Show 1 more changeShow less
    • Primary completion date: Dec 2037 to Dec 2036
  3. Study sites: 3 to 4v5
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2022 to Dec 29, 2022 · Site details revised at 3 of 3 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2022 to Dec 29, 2022
    • Site details revised at 3 of 3 sites
  5. Re-verified, no change to tracked fieldsv3
  6. Start date: Sep 1, 2022 to Dec 2022 Primary and study completion dates: Sep 1, 2037 to Dec 2037v2 Show 1 more changeShow less
    • Primary and study completion dates: Sep 1, 2037 to Dec 2037
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05377307
Lead Sponsor Pell Bio-Med Technology Co., Ltd.
Conditions Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma Grade 3A, Follicular Lymphoma Grade 3B
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov