Status:
RECRUITING
Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
Lead Sponsor:
Pell Bio-Med Technology Co., Ltd.
Conditions:
Diffuse Large B Cell Lymphoma
Large B-cell Lymphoma
Eligibility:
All Genders
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. T...
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 treat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- There are no specific exclusion criteria for this study.
Key Trial Info
Start Date :
December 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05377307
Start Date
December 29 2022
End Date
December 1 2037
Last Update
May 13 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan, 807377
2
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 10025
3
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan, 112201
4
Chi Mei Medical Center
Tainan, Taiwan, 710