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

Recruiting

• Conditions: Large B-cell Lymphoma; Follicular Lymphoma Grade 3A; Primary Mediastinal Large B Cell Lymphoma; Diffuse Large B Cell Lymphoma; Follicular Lymphoma Grade 3B
• Interventions: Genetic: Pell's lentiviral-based gene-edited immune cell therapy

• Registration Number: NCT05377307
• Lead Sponsor: Pell Bio-Med Technology Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Study Start: 2022-12-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2036-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

Exclusion Criteria

There are no specific exclusion criteria for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Pell's lentiviral-based gene-edited immune cell therapy	After completion or early withdraw from the treatment protocol, patients will 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 study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.
Group B	Pell's lentiviral-based gene-edited immune cell therapy	Some patients may require joining other Pell's gene-edited immune cell therapy study during participating in this long-term follow-up study. For such case, the patient could be enrolled into the new treatment protocol. Meanwhile, the patient can be remaining in this long-term follow-up protocol as an inactive participant.

Primary Outcome Measures

Name	Time	Method
To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy	15 years	• Proportion of patients with any events of the following items which are suspected related to previous gene-edited immune cell therapy.; 1. New malignancies; 2. New incidence or exacerbation of a pre-existing neurologic disorder; 3. New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder; 4. New incidence of a hematologic disorder, including hypogammaglobulinemia; 5. New incidence of infection (potentially product-related); 6. Other than the above adverse events, which are suspected related to gene-edited immune cell therapy judged by the investigator

Secondary Outcome Measures

Name	Time	Method
Monitor for Replication Competent of Lentivirus (RCL)	15 years	Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR
Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)	15 years	Proportion of patients with detectable transgene level in peripheral blood by qPCR
Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)	5 years	Persistence of gene-edited immune cells in peripheral blood using flow cytometry
To assess the long-term efficacy of gene-edited immune cells	15 years	1. Proportion of patients with relapse or progress among patients who didn't progress or relapse at study entry/reentry; 2. Incidence of death

Trial Locations

Locations (5)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Chi Mei Medical Center; 🇨🇳 Tainan City, Taiwan

Taipei Medical University - Taipei Medical University Hospital; 🇨🇳 Taipei city, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan