Clinical trial · Observational
Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Follicular Lymphoma Grade 3A | Grade 3a Follicular Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma Grade 3B | Grade 3b Follicular Lymphoma | ALIAS | 0.90 |
| Large B-cell Lymphoma | — | UNRESOLVED | — |
| Primary Mediastinal Large B Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pell's lentiviral-based gene-edited immune cell therapy | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A
- description
- 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.
- interventionNames
- Genetic: Pell's lentiviral-based gene-edited immune cell therapy
- label
- Group B
- description
- 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.
- interventionNames
- Genetic: Pell's lentiviral-based gene-edited immune cell therapy
Primary outcomes (1)
- measure
- To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available