NCT05377307

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

Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 49 (estimated)
• Sponsor: Pell Bio-Med Technology Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diffuse Large B Cell Lymphoma
• Large B-cell Lymphoma
• Primary Mediastinal Large B Cell Lymphoma
• Follicular Lymphoma Grade 3A
• Follicular Lymphoma Grade 3B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-29
• Primary completion: 2036-12-01
• Completion: 2037-12-01
• First posted: 2022-05-17
• Last updated: 2025-05-13

Locations

5 sites across 1 country: Taiwan