Large B-Cell Lymphoma (LBCL)Phase 2NCT07461831
CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma
A Phase 2 study testing CD19/CD22 bispecific CAR-T cells in people with Large B-Cell Lymphoma (LBCL), run by Beijing Tongren Hospital at 1 site in China.
Trial summary
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Large B-Cell Lymphoma (LBCL)
- What is being tested?
- CD19/CD22 bispecific CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 29 Sep 2026
- Phase
- Phase 2
- 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 14 years to 85 years, expected survival > 3 months;
- CD19 positive with or without CD22 positive Large B-cell lymphoma;
- relapsed or refractory disease;
- ECOG-PS score=0-2;
- Having at least one measurable lesion;
- Cardiac function: 1-2 levels;
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- Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
- kidney: Cr≤1.25ULN;
- bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
- No serious allergic constitution;
- No other serious diseases that conflicts with the clinical program;
- No other cancer history;
- No serious mental disorder;
- Informed consent is signed by a subject or his lineal relation.
Who cannot join
- Pregnant or lactating women (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past 4 weeks;
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
About this study
Official title: CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma: A Prospective, Single-Arm, Single-Center, Phase 2 Trial
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.
Read the detailed description
Large B cell lymphoma (LBCL) is the most common aggressive subtype of non-Hodgkin lymphoma (NHL) in adults. While approximately 60% of patients can be cured with first-line therapy, a subset of patients experiences relapse or refractory disease (R/R). The prognosis for R/R LBCL patients is poor, with limited efficacy from traditional treatments such as autologous stem cell transplantation (ASCT) and novel targeted agents. Chimeric antigen receptor-T (CAR-T) cell therapy involves genetically engineering T cells to express chimeric antigen receptors (CARs) that target tumor-specific antigens, enabling precise elimination of tumor cells. CD19 is the most commonly targeted antigen in B-cell malignancies, however, antigen escape following CD19 CAR-T therapy can lead to disease relapse in some patients. Studies indicate that CD22 is widely expressed in B-cell malignancies and exhibits incomplete overlap with CD19 expression, suggesting that dual-target CAR-T therapy may more comprehensively eradicate tumor cells. Therefore, dual-target CAR-T therapy, particularly strategies targeting both CD19 and CD22, has emerged as a promising approach to overcome antigen escape and enhance therapeutic outcomes. In this prospective study, the investigators aimed to evaluate the efficacy and safety of CD19/CD22 bispecific CAR-T cell (CAR2219) therapy in patients with R/R LBCL.
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Being tested
- CD19/CD22 bispecific CAR-T cells
- Keywords
- CD19/CD22, bispecific, CAR-T, Large B-cell Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/CD22 bispecific CAR-T cellsDrug
CD19/CD22-bispecific CAR-T cells were infused at the dosage of 2×10e6/kg
| Study group | Role | What they receive |
|---|---|---|
| CD19/CD22 CAR-T group | Experimental | Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19/CD22 bispecific CAR-T cells was 2×10e6/kg. Receives: Drug: CD19/CD22 bispecific CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
best overall response rate (ORR) as of 3 months post-CAR-T cells infusion
Overall response rate means sum of complete response rate and partial response rate
Measured: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Secondary outcomes (4)
Best Complete Response rate (CR) as of 3 months post-CAR-T cells infusion
CR was defined as complete response evaluated using PET-CT scan
Measured: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Progression free survival (PFS)
PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason
Measured: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
overall survival (OS)
OS was defined from the date of CAR-T infusion to the date fo death
Measured: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
measured using CTCAE version 5.0
Measured: From the day of CAR-T cells infusion to 12 months post-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 posted10 Mar 2026
- Study start1 Feb 2022
- Primary completion18 Apr 2026
- Study completion29 Sep 2026
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 Beijing Tongren HospitalThe 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
- Model description
- In this group, all patients will receive CD19/CD22 bispecific CAR-T cell therapy.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIANG WANG, Beijing Tongren Hospital
- Investigators
- Liang Wang, M.D., Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461831
- Sponsor's protocol ID
- TRhos-CART-02
- Other IDs
- 2025ZD0544300
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2026
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma: A Prospective, Single-Arm, Single-Center, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07461831
- Acronym / sponsor ID
- TRhos-CART-02
- Conditions
- Large B-Cell Lymphoma (LBCL)
- Keywords
- CD19/CD22, bispecific, CAR-T, Large B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 18 Apr 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 10 Mar 2026 (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.
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.
Detailed description
Large B cell lymphoma (LBCL) is the most common aggressive subtype of non-Hodgkin lymphoma (NHL) in adults. While approximately 60% of patients can be cured with first-line therapy, a subset of patients experiences relapse or refractory disease (R/R). The prognosis for R/R LBCL patients is poor, with limited efficacy from traditional treatments such as autologous stem cell transplantation (ASCT) and novel targeted agents. Chimeric antigen receptor-T (CAR-T) cell therapy involves genetically engineering T cells to express chimeric antigen receptors (CARs) that target tumor-specific antigens, enabling precise elimination of tumor cells. CD19 is the most commonly targeted antigen in B-cell malignancies, however, antigen escape following CD19 CAR-T therapy can lead to disease relapse in some patients. Studies indicate that CD22 is widely expressed in B-cell malignancies and exhibits incomplete overlap with CD19 expression, suggesting that dual-target CAR-T therapy may more comprehensively eradicate tumor cells. Therefore, dual-target CAR-T therapy, particularly strategies targeting both CD19 and CD22, has emerged as a promising approach to overcome antigen escape and enhance therapeutic outcomes. In this prospective study, the investigators aimed to evaluate the efficacy and safety of CD19/CD22 bispecific CAR-T cell (CAR2219) therapy in patients with R/R LBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this group, all patients will receive CD19/CD22 bispecific CAR-T cell therapy.
| Arm | Type | Receives |
|---|---|---|
| CD19/CD22 CAR-T group | Experimental | Drug: CD19/CD22 bispecific CAR-T cellsPatients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19/CD22 bispecific CAR-T cells was 2×10e6/kg. |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 14 years to 85 years, expected survival > 3 months;
- CD19 positive with or without CD22 positive Large B-cell lymphoma;
- relapsed or refractory disease;
- ECOG-PS score=0-2;
- Having at least one measurable lesion;
Key exclusion criteria (6 listed)
- Pregnant or lactating women (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past 4 weeks;
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/CD22 bispecific CAR-T cellsCD19/CD22-bispecific CAR-T cells were infused at the dosage of 2×10e6/kg | Drug | CD19/CD22 CAR-T group |
Primary outcome
best overall response rate (ORR) as of 3 months post-CAR-T cells infusion
Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Overall response rate means sum of complete response rate and partial response rate
4 secondary outcomes
Best Complete Response rate (CR) as of 3 months post-CAR-T cells infusion
Time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Progression free survival (PFS)
Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
overall survival (OS)
Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
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 30 Sep 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. This study is not recruiting at the moment.
Liang Wang, M.D. principal investigator
Beijing Tongren Hospital
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/CD22 bispecific CAR-T cells in people with Large B-Cell Lymphoma (LBCL), run by Beijing Tongren Hospital 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 14 inclusion and 6 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 30 Sep 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?
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?
best overall response rate (ORR) as of 3 months post-CAR-T cells infusion (time frame: From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion). 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 30 Sep 2026.