Long-term follow-up of gene-edited immune cell therapy for lymphoma
Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
This study is checking how safe and effective a gene-edited immune cell therapy is for people with lymphoma who received the treatment in the past.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 49 (estimated) |
| Sex | All |
| Sponsor | Pell Bio-Med Technology Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Kaohsiung, Taiwan and 4 other locations) |
| Trial ID | NCT05377307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term safety and efficacy of lentiviral-based gene-edited immune cell therapy in patients who have previously received this treatment. Patients who have completed or withdrawn from other treatment protocols can enroll in this follow-up study at any time within 15 years after their last infusion. The study will monitor for delayed adverse events and overall patient outcomes as recommended by health authorities. The focus is on various types of lymphoma, including Diffuse Large B Cell Lymphoma and Follicular Lymphoma.
Who should consider this trial
Good fit: Ideal candidates are patients who have previously received Pell's lentiviral-based gene-edited immune cell therapy within the last 15 years.
Not a fit: Patients who have never received Pell's lentiviral-based gene-edited immune cell therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effects and safety of gene-edited immune cell therapies for lymphoma patients.
How similar studies have performed: While this study focuses on long-term follow-up, similar gene therapy approaches have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kaohsiung, Taiwan and 4 other locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung, Taiwan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan, Taiwan (Recruiting)
- Taipei Veterans General Hospital — Taipei, Taiwan, Taiwan (Recruiting)
- Chi Mei Medical Center — Tainan, Taiwan (Recruiting)
- Taipei Medical University - Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Cherry Lo, MSC
- Email: cherry.lo@pellbmt.com
- Phone: 886-2-8791-1789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.