NCT05377307 Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
| NCT ID | NCT05377307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pell Bio-Med Technology Co., Ltd. |
| Condition | Diffuse Large B Cell Lymphoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 49 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2036-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 49 participants in total. It began in 2022-12-29 with a primary completion date of 2036-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Chen-Lung Lin, MD
STUDY CHAIR
Pell Bio-Med Technology Co., Ltd.
Frequently Asked Questions
Who can join the NCT05377307 clinical trial?
This trial is open to participants of all sexes, studying Diffuse Large B Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05377307 currently recruiting?
Yes, NCT05377307 is actively recruiting participants. Contact the research team at cherry.lo@pellbmt.com for enrollment information.
Where is the NCT05377307 trial being conducted?
This trial is being conducted at Kaohsiung, Taiwan, Taipei, Taiwan, Taipei, Taiwan, Tainan, Taiwan and 1 additional location.
Who is sponsoring the NCT05377307 clinical trial?
NCT05377307 is sponsored by Pell Bio-Med Technology Co., Ltd.. The principal investigator is Chen-Lung Lin, MD at Pell Bio-Med Technology Co., Ltd.. The trial plans to enroll 49 participants.