Diffuse Large B Cell LymphomaNCT05377307
Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy
An observational study of Diffuse Large B Cell Lymphoma and Large B-cell Lymphoma, run by Pell Bio-Med Technology Co., Ltd. at 5 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma
- What is being tested?
- Pell's lentiviral-based gene-edited immune cell therapy
- Type of treatment
- Injection or infusion
- How many people
- 49 participants
- Where
- 5 sitesTaiwan
- Study dates
- 31 Mar 2023to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes all patients who have ever received Pell's lentiviral-based gene-edited immune cell therapy.
Who may be able to join
- 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.
Who cannot join
- There are no specific exclusion criteria for this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807377
Yi-Chang Liu
- Recruiting
Chi Mei Medical Center
Tainan, 710
Hung-Chang Wu
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 10025
Shang-Ju Wu
- Recruiting
Taipei Veterans General Hospital
Taipei, Taiwan, 112201
Liang-Tsai Hsiao
- Recruiting
Taipei Medical University - Taipei Medical University Hospital
Taipei, 11031
Kuan-Chun Kao
About this study
Official title: Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
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.
Read the 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 treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.
- Conditions
- Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma Grade 3A, Follicular Lymphoma Grade 3B
- Being tested
- Pell's lentiviral-based gene-edited immune cell therapy
- Keywords
- DLBCL(Diffuse Large B Cell Lymphoma), PMLBCL(Primary Mediastinal Large B Cell Lymphoma), FL(Follicular Lymphoma)
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pell's lentiviral-based gene-edited immune cell therapyGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Pell's lentiviral-based gene-edited immune cell therapy | |
| 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. Receives: Genetic: Pell's lentiviral-based gene-edited immune cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy
- Proportion of patients with any events of the following items which are suspected related to previous gene-edited immune cell therapy.
- New malignancies
- New incidence or exacerbation of a pre-existing neurologic disorder
- New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
- New incidence of a hematologic disorder, including hypogammaglobulinemia
- New incidence of infection (potentially product-related)
- Other than the above adverse events, which are suspected related to gene-edited immune cell therapy judged by the investigator
Measured: 15 years
Secondary outcomes (4)
Monitor for Replication Competent of Lentivirus (RCL)
Proportion of patients with detectable RCL in peripheral blood by VSV-G(Vesicular stomatitis virus G) qPCR
Measured: 15 years
Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)
Proportion of patients with detectable transgene level in peripheral blood by qPCR
Measured: 15 years
Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)
Persistence of gene-edited immune cells in peripheral blood using flow cytometry
Measured: 5 years
To assess the long-term efficacy of gene-edited immune cells
- Proportion of patients with relapse or progress among patients who didn't progress or relapse at study entry/reentry
- Incidence of death
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start31 Mar 2023
- Primary completionDec 2036 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pell Bio-Med Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen-Lung Lin, MD, Study chair, Pell Bio-Med Technology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377307
- Sponsor's protocol ID
- PLLV-LTFU-401
- Status last verified
- Oct 2026
- First submitted
- 12 May 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy
- ClinicalTrials.gov ID
- NCT05377307
- Acronym / sponsor ID
- PLLV-LTFU-401
- Conditions
- Diffuse Large B Cell Lymphoma, Large B-cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, Follicular Lymphoma Grade 3A, Follicular Lymphoma Grade 3B
- Keywords
- DLBCL(Diffuse Large B Cell Lymphoma), PMLBCL(Primary Mediastinal Large B Cell Lymphoma), FL(Follicular Lymphoma)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Pell Bio-Med Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 treatment protocol, they may have the option to enter this long-term follow-up study at any time within 15 years after the last lentiviral-based gene-edited immune cell infusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Genetic: Pell's lentiviral-based gene-edited immune cell therapyAfter 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. |
| Group B | – | Genetic: Pell's lentiviral-based gene-edited immune cell therapySome 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes all patients who have ever received Pell's lentiviral-based gene-edited immune cell therapy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pell's lentiviral-based gene-edited immune cell therapyNo 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. | Genetic | Group A, Group B |
Primary outcome
To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy
Time frame: 15 years
• Proportion of patients with any events of the following items which are suspected related to previous gene-edited immune cell therapy. 1. New malignancies 2. New incidence or exacerbation of a pre-existing neurologic disorder 3. New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder 4. New incidence of a hematologic disorder, including hypogammaglobulinemia 5. New incidence of infection (potentially product-related) 6. Other than the above adverse events, which are suspected related to gene-edited immune cell therapy judged by the investigator
4 secondary outcomes
Monitor for Replication Competent of Lentivirus (RCL)
Time frame: 15 years
Monitor the persistence of gene-edited immune cells in peripheral blood(By qPCR)
Time frame: 15 years
Monitor the persistence of gene-edited immune cells in peripheral blood(By Flowcytometry)
Time frame: 5 years
To assess the long-term efficacy of gene-edited immune cells
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chen-Lung Lin, MD study chair
Pell Bio-Med Technology Co., Ltd.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma and Large B-cell Lymphoma, run by Pell Bio-Med Technology Co., Ltd. at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact T. Hsun Lin, MSc (886-2-8791-1789 ext. 3111, hsun.lin@pellbmt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess delayed adverse events which are suspected related to previous gene-edited immune cell therapy (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.