Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
NCT ID: NCT05377307
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
49 participants
OBSERVATIONAL
2022-12-29
2037-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
ALL
No
Sponsors
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Pell Bio-Med Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Chen-Lung Lin, MD
Role: STUDY_CHAIR
Pell Bio-Med Technology Co., Ltd.
Locations
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
Taipei Medical University - Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chao-Hua Chiu
Role: primary
Other Identifiers
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PLLV-LTFU-401
Identifier Type: -
Identifier Source: org_study_id
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