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LymphomaPhase 2NCT07779018

CD19/CD22 CAR-T Consolidation in R/R Aggressive B-Cell Lymphoma After Second-Line Therapy

A Phase 2 study testing CD22/CD19 CAR-T cell immunotherapy in people with Lymphoma, run by Liping Dou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine the efficacy and safety of CD22/CD19-targeted CAR-T cell immunotherapy as consolidation therapy after second-line treatment in patients with high-risk aggressive B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Lymphoma
What is being tested?
CD22/CD19 CAR-T cell immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Apr 2026to 1 Mar 2028
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures; 2. CD19 and/or CD22-positive large B-cell lymphoma (LBCL) diagnosed by cytology or histology according to WHO 2016 criteria, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), etc., whose disease has achieved complete response (CR) after induction treatment with a standard second-line chemotherapy regimen and who are within 3 months from the time of CR.
  • 3. The possible high-risk factors for the patient's onset of the disease are as follows: 1) FISH confirmed high-grade B-cell lymphoma with double or triple strikes, accompanied by MYC and BCL2 and/or BCL6 rearrangements; 2) Advanced B-cell lymphoma with 11q abnormalities/Burkitt like lymphoma with 11q abnormalities; 3) The International Prognostic Index (IPI) at the time of initial diagnosis is 2-5 points; The Age Adjusted International Prognostic Index (aaIPI) is 2-3 points; The National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI) score ranges from 4-8 points in the United States; 4) Immunohistochemical CD5 positivity; 5) Immunohistochemistry suggests dual expression of MYC and BCL-2 (recommended dual expression threshold is MYC ≥ 40%, BCL2 ≥ 50%); 6) Gene sequencing shows TP53 mutation; 7) The second-generation sequencing (NGS) suggests molecular typing as MCD subtype and N1 subtype; 4. Age range from 18 to 85 years old, male or female; 5. Subjects with physical fitness status scores ranging from 0 to 2 in the Eastern Cooperative Oncology Group (ECOG) in the United States; 6. Expected survival period from the date of signing the informed consent form is greater than 3 months; 7. HGB ≥ 60g/L; 8. The absolute value of neutrophils in peripheral blood is ≥ 1000/μl, and the platelet count is ≥ 45000/μl; 9. Liver and kidney function, as well as heart and lung function, meet the following requirements: 1) Total bilirubin (TBIL) ≤ 1.5 times the upper limits of normal (ULN), except for subjects with Gilbert's syndrome; 2) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN; 3) Serum Creatinine (Cr) ≤ 1.5 times ULN or Creatinine Clearance Rate (CCr) ≥ 60mL/min, estimated based on the Cockcroft Gault formula; 4) The left ventricular ejection fraction (LVEF) of the heart is ≥ 50%. Echocardiography (ECHO) confirms no pericardial effusion and no clinically significant arrhythmia; 5) Baseline transcutaneous oxygen saturation under indoor ventilation>92%; 6) No clinically significant pleural effusion; 10. Participants with pregnancy plans must agree to take contraceptive measures for a continuous period of 6 months from before enrollment in the study until the end of the study; If the subject is pregnant or suspected of being pregnant, the researcher should be notified immediately.
  • 11.Patients who are not eligible for hematopoietic stem cell transplantation (HSCT) or who refuse HSCT.

Who cannot join

  • 1. Have received any form of chimeric antigen receptor cell therapy or other genetically modified T cell therapy; 2. Has a history of severe immediate hypersensitivity reactions to aminoglycoside antibiotics and other essential medications; 3. Known history of human immunodeficiency virus (HIV) infection or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as: a. HBV DNA quantification ≥ 2000 IU/ml; b. ALT ≥ 2 times the normal upper limit value; c. Exclude hepatitis caused by the disease itself, medication, or other reasons; All three conditions must be met simultaneously. If a patient is diagnosed with active HBV infection at the time of initial diagnosis and becomes non active HBV infection after anti HBV treatment, they can be included in this study under the premise of sufficient anti HBV treatment; 4. Non hematological tumors (such as lymphoma) associated liver and kidney dysfunction: ALT>3 times the upper limit of normal, AST>3 times the upper limit of normal, TBIL>2 times the upper limit of normal, serum creatinine clearance rate<30 mL/min; 5. History of myocardial infarction, cardiac angioplasty or coronary stent implantation, unstable angina, active arrhythmia, or other clinically significant cardiovascular diseases within the 12 months prior to enrollment; 6. Other serious medical diseases may have an impact on this study (such as diabetes, gastric ulcer, other serious respiratory and circulatory diseases, severe autoimmune diseases or congenital immune defects, severe infection and inability to be effectively controlled), as well as other diseases with high risk of disease change; 7. Has a history of severe immediate hypersensitivity reactions to any medication necessary for use in this study; History of severe allergy to biological products (including antibiotics); 8. Female subjects who are currently pregnant or breastfeeding (with potential risks to the fetus or infant from pre-treatment chemotherapy regimens); 9. The researchers determined that the subjects were unable to complete all the required visit surveys or diagnostic procedures (including medium - and long-term follow-up visits) as per the study protocol, had poor willingness to participate in the study, were unwilling to join and fully comply with the study arrangements, and had insufficient compliance with the study by the subjects and their families. The decision-making power belongs to the researcher; 10. The subjects who have previously suffered from other malignant tumors cannot be included in this study unless they are disease-free and have not received any form of anti-tumor treatment for at least 3 years (except for skin tumors of non malignant melanoma and in situ cancers occurring in the cervix, bladder, breast, etc.); 11. History of receiving live vaccines within 6 weeks prior to initiating the pre-treatment plan; 12. Those who have undergone large-scale surgical treatment (excluding lymph node biopsy) within the past 14 days, or those who are expected to undergo large-scale surgical treatment during the treatment process; 13. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients deemed unsuitable by the researchers to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li-Ping Dou, Dr. contact

86-010-66937232

lipingruirui@163.com

China1 site, 1 recruiting
  • Chinese PLA General Hospital, Beijing, Beijing 100853

    Beijing

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study on CAR-T Cell Immunotherapy Targeting CD22/CD19 for Consolidation Therapy in Relapsed/Refractory Aggressive B-cell Lymphoma After Second-line Treatment

The purpose of this study is to determine the efficacy and safety of CD22/CD19-targeted CAR-T cell immunotherapy as consolidation therapy after second-line treatment in patients with high-risk aggressive B-cell lymphoma.

Read the detailed description

Only a proportion of patients with aggressive B-cell lymphoma can achieve complete response with standard first-line immunochemotherapy such as R-CHOP, and a considerable number of patients experience relapse or disease progression, facing challenges such as drug resistance and poor prognosis.

According to previous National Comprehensive Cancer Network guidelines, patients with high-risk diffuse large B-cell lymphoma (DLBCL) who achieve complete response after first-line induction therapy may receive consolidation treatments such as autologous stem cell transplantation (ASCT) or involved-site radiation therapy (ISRT). However, evidence from the SWOG 9704 study demonstrated that, among patients with intermediate-high or high-risk disease who achieved at least partial response after first-line therapy, ASCT consolidation did not significantly improve progression-free survival (PFS) or overall survival (OS) in the intermediate-high-risk group, with limited benefit observed only in selected high-risk populations. Similarly, the DLCL04 study showed that patients with an age-adjusted International Prognostic Index (aaIPI) score of 2-3 who achieved complete or partial response after first-line therapy did not derive significant benefit from ASCT consolidation.

In the 2024 NCCN guidelines for DLBCL, consolidation strategies after first-line therapy have been largely de-escalated, with recommendations mainly limited to observation or localized radiotherapy in selected cases. For patients who relapse or are refractory after first-line treatment, second-line salvage therapy remains the standard approach; however, even after achieving response to second-line therapy, patients with high-risk features still face a substantial risk of disease progression, and there is currently no well-established consolidation strategy to improve long-term outcomes in this setting.

Chimeric antigen receptor T-cell (CAR-T) immunotherapy has demonstrated remarkable efficacy in relapsed/refractory B-cell malignancies. As a result, CAR-T therapy has been increasingly explored not only as a salvage treatment but also as a potential consolidation strategy. Compared with autologous hematopoietic stem cell transplantation, CAR-T therapy allows for more controllable management of treatment-related toxicities, such as cytokine release syndrome and neurotoxicity, using immunosuppressive agents including glucocorticoids and tocilizumab. In addition, ASCT is associated with higher risks of treatment-related complications, including infection, bleeding, and non-relapse mortality (NRM).

Therefore, for patients with high-risk aggressive B-cell lymphoma who achieve partial or complete response after second-line therapy, there remains an unmet clinical need for effective consolidation strategies to further reduce relapse risk and improve survival outcomes.

Based on these considerations, this study aims to explore the efficacy and safety of CD22/CD19-targeted CAR-T cell immunotherapy as consolidation therapy following second-line treatment in patients with high-risk aggressive B-cell lymphoma, with the goal of improving prognosis and providing a novel therapeutic option in this setting.

Conditions
Lymphoma
Being tested
CD22/CD19 CAR-T cell immunotherapy
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD22/CD19 CAR-T cell immunotherapyDrug

    Patients who achieved complete response (CR) after standard second-line chemotherapy will receive CD19/CD22 CAR-T cell immunotherapy as consolidation treatment. Autologous T cells will be collected and genetically modified to express chimeric antigen receptors targeting CD19 and CD22. Following lymphodepleting chemotherapy, patients will receive a single intravenous infusion of CD19/CD22 CAR-T cells.

Study groups in NCT07779018
Study groupRoleWhat they receive
CD19/CD22 CAR-T cell immunotherapy treatmentExperimentalNot described
Receives: Drug: CD22/CD19 CAR-T cell immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year progression free survival rate (1-year-PFSR)

    The 1-year progression-free survival rate (1-year PFSR) is defined as the proportion of patients who are alive and progression-free at 1 year after CAR-T cell infusion.

    Measured: 1 year after treatment

Secondary outcomes (7)
  1. overall survival (OS)

    Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason.

    Measured: 2 years after treatment

  2. progression free survival (PFS)

    Progression free survival (PFS) refers to the time from treatment to the first lymphoma progression or death of the patient for any reason.

    Measured: 2 years after treatment

  3. time to progression (TTP)

    Time to progression (TTP) refers to the time from treatment to the first lymphoma progression.

    Measured: 2 years after treatment

  4. disease free survival (DFS)

    Disease free survival (DFS) refers to the time from treatment to the first lymphoma recurrence.

    Measured: 2 years after treatment

  5. event free survival (EFS)

    Event Free Survival (EFS) is a commonly used endpoint indicator in clinical trials to evaluate the survival time of patients without any adverse events during a specific time period. These adverse events include but are not limited to disease progression, death, treatment plan changes, and the occurrence of serious side effects.

    Measured: 2 years after treatment

  6. Relapse Rate

    The recurrence rate refers to the proportion of patients with lymphoma recurrence after treatment.

    Measured: 2 years after treatment

  7. Incidence and Severity of Treatment-Emergent Adverse Events

    Include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicities (anemia, leukopenia, neutropenia, thrombocytopenia), infections, electrolyte abnormalities, liver and renal function abnormalities, and other laboratory abnormalities.

    Measured: 2 years after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779018
Sponsor's protocol ID
2026-235
Status last verified
Apr 2026
First submitted
19 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD22/CD19 CAR-T cell immunotherapy in people with Lymphoma, run by Liping Dou 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 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 21 Aug 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 Li-Ping Dou, Dr. (86-010-66937232, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year progression free survival rate (1-year-PFSR) (time frame: 1 year after treatment). 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 21 Aug 2026.

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