Diffuse Large B-cell LymphomaNCT04833504
Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
An observational study of Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Transformed Follicular Lymphoma
- What is being tested?
- CD19 CAR-T Expressing IL7 and CCL19
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2018to 1 Oct 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 39 patients meet including and excluding criteria criteria
Who may be able to join
- All patients who have received the CD19-IL7/CCL19 CAR-T therapy in the earlier enrolled clinical trail and met including and excluding criteria criteria (NCT0325847) Patients who have provided informed consent for the long term follow up study prior to their study participation .
Who cannot join
- There are no specific exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).
Read the detailed description
Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment ( NCT03258047) and will be followed for 5 years post treatment from the last treatment. They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.
- Conditions
- Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Transformed Follicular Lymphoma, Primary Mediastinal Large B-cell Lymphoma
- Being tested
- CD19 CAR-T Expressing IL7 and CCL19
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T Expressing IL7 and CCL19Biological
A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T including duration of response, progression-free survival, overall surviva and objective response rate (CR + PR) .
Measured: 5 years
Secondary outcomes (2)
Evaluate the persistence of CAR-T cells
Levels and persistence of CAR+ T cells in serum samples
Measured: 5 years
Evaluate the incidence of adverse events
The incidence of CRS and CRES; Levels and persistence of cytokines in serum samples;Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death ;B- and T- lymphocyte count;
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start22 Sep 2018
- Primary completion22 Sep 2023
- Study completion1 Oct 2024
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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenbin Qian, Doctor, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833504
- Sponsor's protocol ID
- I20200011057
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2020
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT04833504
- Acronym / sponsor ID
- I20200011057
- Conditions
- Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Transformed Follicular Lymphoma, Primary Mediastinal Large B-cell Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 22 Sep 2018 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Apr 2021 (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.
This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).
Detailed description
Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment ( NCT03258047) and will be followed for 5 years post treatment from the last treatment. They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 39 patients meet including and excluding criteria criteria
Key inclusion criteria (1 listed)
- All patients who have received the CD19-IL7/CCL19 CAR-T therapy in the earlier enrolled clinical trail and met including and excluding criteria criteria (NCT0325847) Patients who have provided informed consent for the long term follow up study prior to their study participation .
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 |
|---|---|---|
| CD19 CAR-T Expressing IL7 and CCL19A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19 | Biological | – |
Primary outcome
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T
Time frame: 5 years
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T including duration of response, progression-free survival, overall surviva and objective response rate (CR + PR) .
2 secondary outcomes
Evaluate the persistence of CAR-T cells
Time frame: 5 years
Evaluate the incidence of adverse events
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
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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. This study is not recruiting at the moment.
Wenbin Qian, Doctor study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site 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 Mantle Cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T (time frame: 5 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 16 Jul 2025.