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

NCT05377307 | Recruiting

• 1 other identifier: PLLV-LTFU-401
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

DLBCL(Diffuse Large B Cell Lymphoma); PMLBCL(Primary Mediastinal Large B Cell Lymphoma); FL(Follicular Lymphoma)

Outcome Measures

Primary Outcomes (1)

• 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. 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

  15 years

Secondary Outcomes (4)

• Monitor for Replication Competent of Lentivirus (RCL)

  15 years

• Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)

  15 years

• Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)

  5 years

• To assess the long-term efficacy of gene-edited immune cells

  15 years

Study Arms (2)

Group A

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.

Genetic: Pell's lentiviral-based gene-edited immune cell therapy

Group B

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.

Genetic: Pell's lentiviral-based gene-edited immune cell therapy

Interventions

Pell's lentiviral-based gene-edited immune cell therapy GENETIC

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.

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes all patients who have ever received Pell's lentiviral-based gene-edited immune cell therapy.

You may qualify if:

• Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.
• The last lentiviral-based gene-edited immune cell infusion within 15 years.
• 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.

Sponsors & Collaborators

• Pell Bio-Med Technology Co., Ltd.: lead

Study Sites (5)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807377, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan, 10025, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan, 112201, Taiwan

RECRUITING

Chi Mei Medical Center

Tainan, 710, Taiwan

RECRUITING

Taipei Medical University - Taipei Medical University Hospital

Taipei, 11031, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Study Officials

• Chen-Lung Lin, MD

  Pell Bio-Med Technology Co., Ltd.

  STUDY CHAIR

Central Study Contacts

Cherry Lo, MSC

CONTACT

886-2-8791-1789; cherry.lo@pellbmt.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: December 29, 2022
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2037
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)