Lymphomas Non-Hodgkin's B-CellPhase 1NCT03029338
CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma
A Phase 1 study testing CD19 CAR T cells in people with Lymphomas Non-Hodgkin's B-Cell and Relapse, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10%… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphomas Non-Hodgkin's B-Cell, Relapse
- What is being tested?
- CD19 CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2017to 22 Jun 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
- Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
- Patients should sign informed consent form.
Who cannot join
- Patients with central nervous system involvement by lymphoma.
- Prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
- Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
- Major surgery within 4 weeks before enrollment.
- Impaired cardiac function:Ejection fraction ≤45 % on MUGA scan. QTc interval > 450msecs on baseline ECG. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
- Administration of live vaccine ≤ 4 weeks before enrollment.
- Other concurrent severe and/or uncontrolled medical conditions: Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
Trial locations and contacts
1 site in 1 country.
About this study
In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.
Read the detailed description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell lymphoma.
- Conditions
- Lymphomas Non-Hodgkin's B-Cell, Relapse
- Being tested
- CD19 CAR T cells
- Keywords
- lymphoma, non-hodgkin, B-cell, CD19 CAR T cells, refractory, relapse
- Medical subject headings
- Lymphoma, B-Cell, Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR T cellsBiological
CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
| Study group | Role | What they receive |
|---|---|---|
| CD19 CAR T cells | Experimental | CD19 CAR T cells will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Receives: Biological: CD19 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: 2 years
Secondary outcomes (4)
Severity of the adverse events
Measured: 2 years
Response rate
Measured: 12 months
Progression-free survival(PFS)
Measured: 2 years
Persistence of CAR T cells in vivo
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start8 Jun 2017
- Primary completion22 May 2019
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphomas Non-Hodgkin's B-CellStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Responsible party
- Sponsor
- Investigators
- Dehui Zou, Dr., Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029338
- Sponsor's protocol ID
- QT2016003
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2017
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu W, Xie T, Zhang Z, Huang W, Liu H, Sui W, Deng S, Lyu R, Wang Y, Wang Q, Xiong W, Xu Y, Lyu L, Ma Y, Qiu L, Wang J, Zou D. Long-term outcomes of CNCT19 chimeric antigen receptor T-cell therapy in relapsed or refractory aggressive B-cell lymphoma. Chin Med J (Engl). 2026 May 5;139(9):1367-1374. doi: 10.1097/CM9.0000000000003716. Epub 2025 Sep 17.
PubMed 40960310
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03029338
- Acronym / sponsor ID
- QT2016003
- Conditions
- Lymphomas Non-Hodgkin's B-Cell, Relapse
- Keywords
- lymphoma, non-hodgkin, B-cell, CD19 CAR T cells, refractory, relapse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 24 Jan 2017 (estimated)
- 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.
In this single-center, open-label, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with relapsed or refractory CD19 positive B-cell lymphoma.
Detailed description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 CAR T cells | Experimental | Biological: CD19 CAR T cellsCD19 CAR T cells will be intravenously infused to patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 70 years with relapsed or refractory CD19 positive B-cell lymphoma.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
- Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
- Patients should sign informed consent form.
Key exclusion criteria (8 listed)
- Patients with central nervous system involvement by lymphoma.
- Prior chemotherapy within 2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine and thioguanine are permitted within 2 weeks of enrollment as maintenance or to reduce tumor load.
- Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have≥ grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
- Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
- Major surgery within 4 weeks before enrollment.
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 cellsCD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB. | Biological | CD19 CAR T cells |
Primary outcome
Number of patients with adverse events
Time frame: 2 years
4 secondary outcomes
Severity of the adverse events
Time frame: 2 years
Response rate
Time frame: 12 months
Progression-free survival(PFS)
Time frame: 2 years
Persistence of CAR T cells in vivo
Time frame: 2 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 11 Feb 2026.
- Derived from this study: PubMed 40960310Liu W, Xie T, Zhang Z, Huang W, Liu H, Sui W, Deng S, Lyu R, Wang Y, Wang Q, Xiong W, Xu Y, Lyu L, Ma Y, Qiu L, Wang J, Zou D. Long-term outcomes of CNCT19 chimeric antigen receptor T-cell therapy in relapsed or refractory aggressive B-cell lymphoma. Chin Med J (Engl). 2026 May 5;139(9):1367-1374. doi: 10.1097/CM9.0000000000003716. Epub 2025 Sep 17.
- Individual participant dataSharing planned: Undecided
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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.
Dehui Zou, Dr. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19 CAR T cells in people with Lymphomas Non-Hodgkin's B-Cell and Relapse, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 8 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 11 Feb 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patients with adverse events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029338, which also lists 1 linked publication.
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 11 Feb 2026.