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

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377307
• Other study ID #: PLLV-LTFU-401
• Status: Recruiting
• Start date: December 29, 2022
• Est. completion date: December 2037

Study information

• Verified date: April 2024
• Source: Pell Bio-Med Technology Co., Ltd.
• Contact: Cherry Lo, MSC
• Phone: 886-2-8791-1789
• Email: cherry.lo[@]pellbmt.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: December 2037
• Est. primary completion date: December 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Taipei Medical University - Taipei Medical University Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Pell Bio-Med Technology Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy	• Proportion of patients with any events of the following items which are suspected related to previous gene-edited immune cell therapy.; New malignancies; New incidence or exacerbation of a pre-existing neurologic disorder; New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder; New incidence of a hematologic disorder, including hypogammaglobulinemia; New incidence of infection (potentially product-related); Other than the above adverse events, which are suspected related to gene-edited immune cell therapy judged by the investigator	15 years
Secondary	Monitor for Replication Competent of Lentivirus (RCL)	Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR	15 years
Secondary	Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)	Proportion of patients with detectable transgene level in peripheral blood by qPCR	15 years
Secondary	Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)	Persistence of gene-edited immune cells in peripheral blood using flow cytometry	5 years
Secondary	To assess the long-term efficacy of gene-edited immune cells	Proportion of patients with relapse or progress among patients who didn't progress or relapse at study entry/reentry; Incidence of death	15 years