LymphomaPhase 2NCT07094477
Study of Targeted CD22/CD19 CAR-T Therapy for First-line Consolidation of B-cell Lymphoma
A Phase 2 study testing CD22/CD19 CAR-T cell immunotherapy in people with Lymphoma, run by Daihong Liu at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy of high-risk invasive 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Mar 2027
- 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 standards, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma (HGBL), etc.: 1) The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or 2) The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset; 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.
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.
About this study
Official title: An Exploratory Clinical Study on Targeted CD22/CD19 CAR-T Cell Immunotherapy for First-line Consolidation Therapy of High-risk Invasive B-cell Lymphoma
The purpose of this study is to determine the efficacy and safety of targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy of high-risk invasive B-cell lymphoma.
Read the detailed description
Only a portion of patients with invasive B-cell lymphoma can achieve complete response through standard combination therapy with R-CHOP, and a considerable number of patients have poor prognosis and face treatment difficulties such as drug resistance and recurrence.
In the previous guidelines of the National Comprehensive Cancer Network (NCCN) in the United States, high-risk diffuse large B-cell lymphoma (defined as stage III-IV, or stage I-II with extensive mesenteric involvement) patients showed complete response after completing six cycles of first-line induction therapy. Subsequently, autologous stem cell transplantation (ASCT) and involved site radiation therapy (ISRT) can be used for consolidation treatment. However, the SWOG 9704 study found that patients with medium to high risk/high-risk B-cell lymphoma who achieved at least partial response to first-line treatment and received ASCT consolidation therapy did not benefit from ASCT in terms of progression free survival/overall survival in the medium to high risk group, only in terms of overall survival and disease-free survival in the high-risk group. In addition, the DLCL04 study showed that medium to high-risk or high-risk patients with an Age Adjusted International Prognostic Index (aaIPI) score of 2-3 who achieved complete or partial response to first-line treatment did not benefit from ASCT.
In the 2024 NCCN guidelines for diffuse large B-cell lymphoma, first-line consolidation therapy for high-risk diffuse large B-cell lymphoma patients after induction therapy only includes close follow-up and radiation consolidation therapy for the affected areas of the original mass and bone lesions. There is no more aggressive treatment strategy to positively address the relatively high risk of disease recurrence and progression in this group of high-risk patients.
CAR-T cell immunotherapy has achieved good clinical therapeutic effects in hematological tumors. After induction therapy, first-line CAR-T cell immunotherapy consolidation therapy is expected to improve the disease prognosis of high-risk invasive B-cell lymphoma patients and bring long-term survival benefits. Compared to CAR-T cell immunotherapy, which can directly control adverse reactions with immunosuppressive drugs such as glucocorticoids, the risk of autologous hematopoietic stem cell transplantation is higher, and patients have a greater risk of non recurrent mortality (NRM) due to complications such as infection and bleeding. The latest version of the NCCN guidelines for diffuse large B-cell lymphoma no longer recommends autologous hematopoietic stem cell transplantation as the first-line consolidation treatment for high-risk diffuse large B-cell lymphoma. Therefore, new first-line consolidation treatment plans after induction therapy are still needed to further improve the survival prognosis of high-risk invasive B-cell lymphoma patients.
Based on the many difficulties that still exist in the first-line standard treatment plan for high-risk invasive B-cell lymphoma patients, this study plans to explore the effectiveness and safety of CD22/CD19 CAR-T cell immunotherapy as first-line consolidation therapy for high-risk invasive B-cell lymphoma patients after standard first-line induction therapy, in order to improve the prognosis of such patients and provide new treatment options for first-line consolidation therapy of high-risk invasive B-cell lymphoma.
- Conditions
- Lymphoma
- Being tested
- CD22/CD19 CAR-T cell immunotherapy
- Keywords
- B-cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, B-Cell
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
Also called CAR-T cell immunotherapy
targeted CD22/CD19 CAR-T cell immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | patients with high-risk invasive B-cell lymphoma who accept targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy 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-year progression free survival rate (1-year-PFS)
The 1-year progression free survival rate (1-year-PFS) of targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy of high-risk invasive B-cell lymphoma refers to the proportion of disease progression that occurs within one year after treatment in patients.
Measured: 1 year after treatment
Secondary outcomes (7)
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: 1 year after treatment
time to progression (TTP)
Time to progression (TTP) refers to the time from treatment to the first lymphoma progression.
Measured: 1 year after treatment
disease free survival (DFS)
Disease free survival (DFS) refers to the time from treatment to the first lymphoma recurrence.
Measured: 1 year after treatment
duration of response (DOR)
Duration of Response (DOR) refers to the time from the first assessment of a lymphoma as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.
Measured: 1 year after treatment
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: 1 year after treatment
recurrence rate
The recurrence rate refers to the proportion of patients with lymphoma recurrence after treatment.
Measured: 1 year after treatment
Treatment-related safety indicators
The safety of this CD22/CD19 CAR-T cell immunotherapy.
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- Prospective Assignment
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daihong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daihong Liu, Chinese PLA General Hospital
- Investigators
- Dai-Hong Liu, Dr., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094477
- Sponsor's protocol ID
- S2025-124-01
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data contain sensitive personal health information
Publications
Khan AN, Asija S, Pendhari J, Purwar R. CAR-T cell therapy in hematological malignancies: Where are we now and where are we heading for? Eur J Haematol. 2024 Jan;112(1):6-18. doi: 10.1111/ejh.14076. Epub 2023 Aug 7.
PubMed 37545253Baker DJ, Arany Z, Baur JA, Epstein JA, June CH. CAR T therapy beyond cancer: the evolution of a living drug. Nature. 2023 Jul;619(7971):707-715. doi: 10.1038/s41586-023-06243-w. Epub 2023 Jul 26.
PubMed 37495877CD19/CD22 Dual-Targeted CAR-T Therapy Active in Relapsed/Refractory DLBCL. Oncologist. 2020 Jul;25 Suppl 1(Suppl 1):S12-S13. doi: 10.1634/theoncologist.2020-0560. Epub 2020 Jun 26.
PubMed 32589304Nguyen TT, Thanh Nhu N, Chen CL, Lin CF. Effectiveness and safety of CD22 and CD19 dual-targeting chimeric antigen receptor T-cell therapy in patients with relapsed or refractory B-cell malignancies: A meta-analysis. Cancer Med. 2023 Sep;12(18):18767-18785. doi: 10.1002/cam4.6497. Epub 2023 Sep 5.
PubMed 37667978Zeng C, Cheng J, Li T, Huang J, Li C, Jiang L, Wang J, Chen L, Mao X, Zhu L, Lou Y, Zhou J, Zhou X. Efficacy and toxicity for CD22/CD19 chimeric antigen receptor T-cell therapy in patients with relapsed/refractory aggressive B-cell lymphoma involving the gastrointestinal tract. Cytotherapy. 2020 Mar;22(3):166-171. doi: 10.1016/j.jcyt.2020.01.008. Epub 2020 Feb 13.
PubMed 32063474Spiegel JY, Patel S, Muffly L, Hossain NM, Oak J, Baird JH, Frank MJ, Shiraz P, Sahaf B, Craig J, Iglesias M, Younes S, Natkunam Y, Ozawa MG, Yang E, Tamaresis J, Chinnasamy H, Ehlinger Z, Reynolds W, Lynn R, Rotiroti MC, Gkitsas N, Arai S, Johnston L, Lowsky R, Majzner RG, Meyer E, Negrin RS, Rezvani AR, Sidana S, Shizuru J, Weng WK, Mullins C, Jacob A, Kirsch I, Bazzano M, Zhou J, Mackay S, Bornheimer SJ, Schultz L, Ramakrishna S, Davis KL, Kong KA, Shah NN, Qin H, Fry T, Feldman S, Mackall CL, Miklos DB. CAR T cells with dual targeting of CD19 and CD22 in adult patients with recurrent or refractory B cell malignancies: a phase 1 trial. Nat Med. 2021 Aug;27(8):1419-1431. doi: 10.1038/s41591-021-01436-0. Epub 2021 Jul 26.
PubMed 34312556Wei G, Zhang Y, Zhao H, Wang Y, Liu Y, Liang B, Wang X, Xu H, Cui J, Wu W, Zhao K, Nagler A, Chang AH, Hu Y, Huang H. CD19/CD22 Dual-Targeted CAR T-cell Therapy for Relapsed/Refractory Aggressive B-cell Lymphoma: A Safety and Efficacy Study. Cancer Immunol Res. 2021 Sep;9(9):1061-1070. doi: 10.1158/2326-6066.CIR-20-0675. Epub 2021 Jul 21.
PubMed 34290048
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on Targeted CD22/CD19 CAR-T Cell Immunotherapy for First-line Consolidation Therapy of High-risk Invasive B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07094477
- Acronym / sponsor ID
- S2025-124-01
- Conditions
- Lymphoma
- Keywords
- B-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Daihong LiuUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Jul 2025 (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.
The purpose of this study is to determine the efficacy and safety of targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy of high-risk invasive B-cell lymphoma.
Detailed description
Only a portion of patients with invasive B-cell lymphoma can achieve complete response through standard combination therapy with R-CHOP, and a considerable number of patients have poor prognosis and face treatment difficulties such as drug resistance and recurrence.
In the previous guidelines of the National Comprehensive Cancer Network (NCCN) in the United States, high-risk diffuse large B-cell lymphoma (defined as stage III-IV, or stage I-II with extensive mesenteric involvement) patients showed complete response after completing six cycles of first-line induction therapy. Subsequently, autologous stem cell transplantation (ASCT) and involved site radiation therapy (ISRT) can be used for consolidation treatment. However, the SWOG 9704 study found that patients with medium to high risk/high-risk B-cell lymphoma who achieved at least partial response to first-line treatment and received ASCT consolidation therapy did not benefit from ASCT in terms of progression free survival/overall survival in the medium to high risk group, only in terms of overall survival and disease-free survival in the high-risk group. In addition, the DLCL04 study showed that medium to high-risk or high-risk patients with an Age Adjusted International Prognostic Index (aaIPI) score of 2-3 who achieved complete or partial response to first-line treatment did not benefit from ASCT.
In the 2024 NCCN guidelines for diffuse large B-cell lymphoma, first-line consolidation therapy for high-risk diffuse large B-cell lymphoma patients after induction therapy only includes close follow-up and radiation consolidation therapy for the affected areas of the original mass and bone lesions. There is no more aggressive treatment strategy to positively address the relatively high risk of disease recurrence and progression in this group of high-risk patients.
CAR-T cell immunotherapy has achieved good clinical therapeutic effects in hematological tumors. After induction therapy, first-line CAR-T cell immunotherapy consolidation therapy is expected to improve the disease prognosis of high-risk invasive B-cell lymphoma patients and bring long-term survival benefits. Compared to CAR-T cell immunotherapy, which can directly control adverse reactions with immunosuppressive drugs such as glucocorticoids, the risk of autologous hematopoietic stem cell transplantation is higher, and patients have a greater risk of non recurrent mortality (NRM) due to complications such as infection and bleeding. The latest version of the NCCN guidelines for diffuse large B-cell lymphoma no longer recommends autologous hematopoietic stem cell transplantation as the first-line consolidation treatment for high-risk diffuse large B-cell lymphoma. Therefore, new first-line consolidation treatment plans after induction therapy are still needed to further improve the survival prognosis of high-risk invasive B-cell lymphoma patients.
Based on the many difficulties that still exist in the first-line standard treatment plan for high-risk invasive B-cell lymphoma patients, this study plans to explore the effectiveness and safety of CD22/CD19 CAR-T cell immunotherapy as first-line consolidation therapy for high-risk invasive B-cell lymphoma patients after standard first-line induction therapy, in order to improve the prognosis of such patients and provide new treatment options for first-line consolidation therapy of high-risk invasive B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Assignment
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Drug: CD22/CD19 CAR-T cell immunotherapypatients with high-risk invasive B-cell lymphoma who accept targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 standards, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma (HGBL), etc.: 1) The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or 2) The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset; 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| CD22/CD19 CAR-T cell immunotherapyAlso: CAR-T cell immunotherapytargeted CD22/CD19 CAR-T cell immunotherapy | Drug | Assigned Interventions |
Primary outcome
1-year progression free survival rate (1-year-PFS)
Time frame: 1 year after treatment
The 1-year progression free survival rate (1-year-PFS) of targeted CD22/CD19 CAR-T cell immunotherapy for first-line consolidation therapy of high-risk invasive B-cell lymphoma refers to the proportion of disease progression that occurs within one year after treatment in patients.
7 secondary outcomes
overall survival (OS)
Time frame: 1 year after treatment
time to progression (TTP)
Time frame: 1 year after treatment
disease free survival (DFS)
Time frame: 1 year after treatment
duration of response (DOR)
Time frame: 1 year after treatment
event free survival (EFS)
Time frame: 1 year after treatment
recurrence rate
Time frame: 1 year after treatment
Treatment-related safety indicators
Time frame: 1 year after treatment
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 30 Jul 2025.
- Background: PubMed 37545253Khan AN, Asija S, Pendhari J, Purwar R. CAR-T cell therapy in hematological malignancies: Where are we now and where are we heading for? Eur J Haematol. 2024 Jan;112(1):6-18. doi: 10.1111/ejh.14076. Epub 2023 Aug 7.
- Background: PubMed 37495877Baker DJ, Arany Z, Baur JA, Epstein JA, June CH. CAR T therapy beyond cancer: the evolution of a living drug. Nature. 2023 Jul;619(7971):707-715. doi: 10.1038/s41586-023-06243-w. Epub 2023 Jul 26.
- Background: PubMed 32589304CD19/CD22 Dual-Targeted CAR-T Therapy Active in Relapsed/Refractory DLBCL. Oncologist. 2020 Jul;25 Suppl 1(Suppl 1):S12-S13. doi: 10.1634/theoncologist.2020-0560. Epub 2020 Jun 26.
- Background: PubMed 37667978Nguyen TT, Thanh Nhu N, Chen CL, Lin CF. Effectiveness and safety of CD22 and CD19 dual-targeting chimeric antigen receptor T-cell therapy in patients with relapsed or refractory B-cell malignancies: A meta-analysis. Cancer Med. 2023 Sep;12(18):18767-18785. doi: 10.1002/cam4.6497. Epub 2023 Sep 5.
- Background: PubMed 32063474Zeng C, Cheng J, Li T, Huang J, Li C, Jiang L, Wang J, Chen L, Mao X, Zhu L, Lou Y, Zhou J, Zhou X. Efficacy and toxicity for CD22/CD19 chimeric antigen receptor T-cell therapy in patients with relapsed/refractory aggressive B-cell lymphoma involving the gastrointestinal tract. Cytotherapy. 2020 Mar;22(3):166-171. doi: 10.1016/j.jcyt.2020.01.008. Epub 2020 Feb 13.
- Background: PubMed 34312556Spiegel JY, Patel S, Muffly L, Hossain NM, Oak J, Baird JH, Frank MJ, Shiraz P, Sahaf B, Craig J, Iglesias M, Younes S, Natkunam Y, Ozawa MG, Yang E, Tamaresis J, Chinnasamy H, Ehlinger Z, Reynolds W, Lynn R, Rotiroti MC, Gkitsas N, Arai S, Johnston L, Lowsky R, Majzner RG, Meyer E, Negrin RS, Rezvani AR, Sidana S, Shizuru J, Weng WK, Mullins C, Jacob A, Kirsch I, Bazzano M, Zhou J, Mackay S, Bornheimer SJ, Schultz L, Ramakrishna S, Davis KL, Kong KA, Shah NN, Qin H, Fry T, Feldman S, Mackall CL, Miklos DB. CAR T cells with dual targeting of CD19 and CD22 in adult patients with recurrent or refractory B cell malignancies: a phase 1 trial. Nat Med. 2021 Aug;27(8):1419-1431. doi: 10.1038/s41591-021-01436-0. Epub 2021 Jul 26.
- Background: PubMed 34290048Wei G, Zhang Y, Zhao H, Wang Y, Liu Y, Liang B, Wang X, Xu H, Cui J, Wu W, Zhao K, Nagler A, Chang AH, Hu Y, Huang H. CD19/CD22 Dual-Targeted CAR T-cell Therapy for Relapsed/Refractory Aggressive B-cell Lymphoma: A Safety and Efficacy Study. Cancer Immunol Res. 2021 Sep;9(9):1061-1070. doi: 10.1158/2326-6066.CIR-20-0675. Epub 2021 Jul 21.
- Individual participant dataSharing planned: No. Data contain sensitive personal health information
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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.
Dai-Hong Liu, Dr. principal investigator
Chinese PLA General 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 CD22/CD19 CAR-T cell immunotherapy in people with Lymphoma, run by Daihong Liu 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: under way, not looking for participants, as of the sponsor's last update on 30 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.
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?
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?
1-year progression free survival rate (1-year-PFS) (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?
On the ClinicalTrials.gov record for NCT07094477, which also lists 7 linked publications.
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 Jul 2025.