Large B-Cell Lymphoma (LBCL)Phase 2NCT04661020
CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
A Phase 2 study testing CD19 CAR-T cells in people with Large B-Cell Lymphoma (LBCL), run by Zhejiang University at 1 site in China.
Trial summary
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL)
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2020to 20 Dec 2026
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age no less than 18, no gender limit;
- Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
- Confirmed CD19 and CD20 postive expressions in lymphoma cells
- ECOG score 0-2;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
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- No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- Estimated survival time ≥ 3 months;
- Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Who cannot join
- Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (<5 times) ;
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- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
About this study
Official title: Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Read the detailed description
This study is indicated for patients with CD19+ newly diagnosed high-risk large B-cell lymphoma. This study is an investigator-initiated, single-center, single-arm phase II clinical trial of rituximab, lenalidomide, and zanubrutinib (ZR2) with Sequential CAR-T cell as first-line therapy for newly diagnosed high-risk LBCL. Primary objective is to explore the efficacy and also safety.
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Being tested
- CD19 CAR-T cells
- Keywords
- CD19, Large B-Cell Lymphoma, CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T cellsDrug
Also called CD19 CAR-T cells injection
Each subject receive CD19 CAR T-cells by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Administration of CD19 CAR T-cells | Experimental | Not described Receives: Drug: CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate after CD19 CAR-T cell therapy
Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy
Measured: 3 months after CD19 CAR-T cell therapy
Secondary outcomes (5)
Overall response rate (ORR)
Assessment of ORR after ZR2 and CAR-T cell therapy
Measured: After ZR2, 3 months after CAR-T cell therapy
Overall survival (OS)
From the start of treatment to death or the last visit
Measured: Up to 2 years after CD19 CAR-T cells infusion
Progression-free survival (PFS)
From the start of the treatment to the occurrence of any event, including death, disease progression (any one occurs first), or the last visit
Measured: Up to 2 years after CD19 CAR-T cells infusion
Duration of response (DOR)
among patients experiencing an objective response, defined as the time from the first objective response to events of disease progression or death from any cause
Measured: Up to 2 years after CD19 CAR-T cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: Up to 2 years after CD19 targeted CAR T-cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start3 Dec 2020
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-Cell Lymphoma (LBCL)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661020
- Sponsor's protocol ID
- CD19-003
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04661020
- Acronym / sponsor ID
- CD19-003
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Keywords
- CD19, Large B-Cell Lymphoma, CAR-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 9 Dec 2020 (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.
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Detailed description
This study is indicated for patients with CD19+ newly diagnosed high-risk large B-cell lymphoma. This study is an investigator-initiated, single-center, single-arm phase II clinical trial of rituximab, lenalidomide, and zanubrutinib (ZR2) with Sequential CAR-T cell as first-line therapy for newly diagnosed high-risk LBCL. Primary objective is to explore the efficacy and also safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CD19 CAR T-cells | Experimental | Drug: CD19 CAR-T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age no less than 18, no gender limit;
- Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
- Confirmed CD19 and CD20 postive expressions in lymphoma cells
- ECOG score 0-2;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
Key exclusion criteria (9 listed)
- Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
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 cellsAlso: CD19 CAR-T cells injectionEach subject receive CD19 CAR T-cells by intravenous infusion | Drug | Administration of CD19 CAR T-cells |
Primary outcome
Complete remission rate after CD19 CAR-T cell therapy
Time frame: 3 months after CD19 CAR-T cell therapy
Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy
5 secondary outcomes
Overall response rate (ORR)
Time frame: After ZR2, 3 months after CAR-T cell therapy
Overall survival (OS)
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Progression-free survival (PFS)
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Duration of response (DOR)
Time frame: Up to 2 years after CD19 CAR-T cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years after CD19 targeted CAR T-cells infusion
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 7 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD19 CAR-T cells in people with Large B-Cell Lymphoma (LBCL), run by Zhejiang University 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 9 inclusion and 9 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 7 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate after CD19 CAR-T cell therapy (time frame: 3 months after CD19 CAR-T cell therapy). 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 7 Apr 2026.