Diffuse Large B Cell LymphomaPhase 1/2NCT06829771
Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
A Phase 1/2 study testing TQB2825 injection +R-CHOP regimen and TQB2825 injection + GemOx in people with Diffuse Large B Cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 25 sites in China.
Trial summary
To explore the efficacy and safety of TQB2825 injection combined immunochemotherapy in subjects with untreated or R/R DLBCL. The efficacy evaluation indicators are objective response rate (ORR), complete response rate (CR rate),progression free survival (PFS), duration of response (DOR) and overall survival(OS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- TQB2825 injection +R-CHOP regimen and TQB2825 injection + GemOx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 25 sitesChina
- Study dates
- 23 Apr 2025to Dec 2026
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Age 18 to under 80 years old (calculated from the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
- Life expectancy greater than 12 weeks;
- In the dose expansion phase, previously untreated patients with International Prognostic Index (IPI) scores of 2-5;
- A confirmed diagnosis of diffuse large B-cell lymphoma or grade 3b follicular lymphoma, in accordance with the 2022 World Health Organization (WHO) diagnostic criteria, based on histology or cytology (including diffuse large B-cell lymphoma-not otherwise specified and transformed from indolent lymphomas, not allowing for the following types or components: double-hit, triple-hit, or high-grade B-cell lymphoma-not otherwise specified, mediastinal large B-cell lymphoma, T/histiocyte-rich large B-cell lymphoma, human herpesvirus 8 (HHV8)-positive/primary effusion lymphoma, Anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma, Burkitt's lymphoma, and Hodgkin's lymphoma, etc.);
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- Immunophenotypic analysis shows that the tumor is CD20 positive;
- Previous treatment meets the following criteria:
- Combined with R-CHOP patients: previously untreated diffuse large B-cell lymphoma patients, allowing for corticosteroid pre-treatment (with or without vincristine) or non-curative palliative local radiotherapy.
- Combined with GemOx patients: patients with diffuse large B-cell lymphoma who have received at least one line of systemic treatment (including at least one line with CD20 monoclonal antibody) and are not suitable for hematopoietic stem cell transplantation or have failed treatment after transplantation or relapsed, and whose disease progressed during the most recent treatment or relapsed after completion of treatment or confirmed no objective response after adequate treatment.
- According to the 2014 Lugano criteria, there is at least one measurable lesion, i.e., lymph node lesions with a long diameter >15 mm or extranodal lesions with a long diameter >10 mm based on CT cross-sectional imaging; Positron emission tomography (PET)-computed tomography (CT) scan shows PET positivity;
- Laboratory tests meet the following criteria (not corrected with blood transfusion or hematopoietic growth factors within 14 days before screening):
- Hemoglobin (HGB) ≥80g/L;
- Absolute neutrophil count (NEUT) ≥1.0×10∧9/L;
- Platelet count (PLT) ≥ 75×10∧9/L (if accompanied by bone marrow invasion, platelets ≥50×10∧9/L).
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If accompanied by liver metastasis, then ALT and AST ≤ 5 ULN;
- Serum creatinine (CR) ≤ 1.5 ULN or estimated glomerular filtration rate ≥50 ml/min by the Cockcroft-Gault formula.
- Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (not on anticoagulant therapy);
- Women of childbearing age must agree to use effective contraceptive measures during the study and for 12 months after the study ends, with a negative serum or urine pregnancy test within 7 days before study enrollment; men must agree to use effective contraceptive measures during the study and for 12 months after the study ends.
Who cannot join
- The subject has had or currently has other malignant tumors that occurred within 5 years before the first dose of the study drug. The following two situations are eligible for enrollment: other malignant tumors that have been treated with single surgery and have achieved continuous 5 years of disease-free survival (DFS); cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane)];
- Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized with hormone replacement therapy, which are deemed to have no safety risks by the investigator;
- Received major surgical treatment, significant traumatic injury within 4 weeks before the first dose, or expected to undergo major surgery during the study treatment period, or has long-term unhealed wounds or fractures;
- Any subject with bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;
- A history of arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, or any other history of serious thromboembolism (thrombosis from implanted venous access ports or catheters, or superficial vein thrombosis is not considered "serious" thromboembolism);
- Clinically significant uncontrollable pleural effusion requiring repeated drainage, ascites, moderate or greater pericardial effusion;
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- Decompensated cirrhosis (Child-Pugh liver function rating of B or C) and active hepatitis (hepatitis B reference: positive HBsAg, and positive hepatitis B virus (HBV) DNA or detection value exceeding the lower limit of detection; hepatitis C reference: positive HCV antibody, and positive hepatitis C virus (HCV) RNA or detection value exceeding the lower limit of detection); Note: Subjects with hepatitis B who are positive for HBsAg, regardless of whether their HBV DNA is detectable, must continue antiviral treatment (nucleoside analogs recommended) and regularly monitor HBV DNA; for subjects with hepatitis B who are positive for HBcAb but negative for HBsAg, regular monitoring of HBV DNA is required, and prophylactic antiviral treatment is recommended; for hepatitis C subjects, regular monitoring of HCV RNA is required.
- Pulmonary diseases, including any of the following conditions:
- Past or present non-infectious pneumonia requiring treatment with corticosteroids (including but not limited to acute respiratory distress syndrome, acute hypersensitivity pneumonia, drug-related pneumonia, bronchospasm, acute interstitial pneumonia, idiopathic pulmonary interstitial fibrosis, etc.);
- Past or present chronic obstructive pulmonary disease (COPD), and forced expiratory volume in one second (FEV1) <60% (predicted value);
- Brain or mental abnormalities, including any of the following conditions:
- A history of substance abuse that cannot be quit;
- Accompanying or past central nervous system disease history, including epileptic seizures, hemorrhagic/ischemic stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, paralysis, aphasia, mental illness, consciousness disturbance, unexplained coma, neuropathy, organic brain syndrome, etc.;
- Brain MRI evidence indicating inflammatory lesions and/or vasculitis;
- Cerebrovascular accidents, cerebral infarction, etc., within 6 months before the first dose;
- Major cardiovascular diseases, including any of the following conditions:
- Heart failure of more than grade II according to the New York Heart Association (NYHA) standards or cardiac ultrasound examination: Left ventricular ejection fraction (LVEF) <50%;
- A history of clinically significant ventricular arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia) or arrhythmias requiring continuous antiarrhythmic drug treatment;
- A history of myocardial infarction, serious arrhythmias, unstable angina, etc., within 6 months before the first dose;
- The Fridericia-corrected QT interval (QTcF) is >450 milliseconds (msec) for males and >470 msec for females (if QTc is abnormal, it can be measured three times continuously with an interval of more than 2 minutes, and the average value can be taken);
- A history or family history of congenital long QT syndrome;
- Hypertension that cannot be controlled with a combination of two drugs (at least two measurement results are systolic pressure ≥160 mmHg, diastolic pressure ≥100 mmHg);
- Active or uncontrolled infections (≥CTC AE grade 2 infections), including bacterial, fungal, or viral infections (including but not limited to active pneumonia, syphilis, tuberculosis, and Coronavirus disease 2019 (COVID-19), etc. During the screening period, Polymerase chain reaction (PCR) testing or two antigen tests for COVID-19 must be performed (with an interval of at least 24 hours), and the test results must be negative to be eligible. Subjects who do not meet the COVID-19 infection eligibility criteria must fail the screening, and can only be re-screened under the following conditions: asymptomatic subjects at least 10 days after the first positive test result, or symptomatic subjects at least 10 days after the onset of symptoms);
- Renal failure requiring hemodialysis or peritoneal dialysis, history of nephrotic syndrome;
- A history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;
- Having or having had autoimmune diseases that require treatment, subjects receiving stable replacement therapy for hypothyroidism, and type 1 diabetes can be enrolled.
- Prepared for or having received organ transplantation, or having obvious host-graft reactions, or having received allogeneic hematopoietic stem cell transplantation in the past;
- Need for systemic immunosuppressive treatment, including but not limited to: use of cyclosporine, tacrolimus, etc., within 4 weeks before the first dose, receiving high-dose glucocorticoid therapy (prednisone >30 mg/day or equivalent dose of other glucocorticoids), or receiving any other immunosuppressive treatment. Subjects receiving inhaled or local corticosteroid treatment, or those who have been receiving a stable dose of prednisone <10 mg/day or equivalent dose of other glucocorticoids for systemic treatment for at least 4 weeks before the first dose, or those receiving prophylactic medication to prevent infusion reactions before the administration of the trial medication can be enrolled;
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH);
- For relapsed/refractory patients, previous anti-tumor treatments:
- Received chemotherapy, immunotherapy, monoclonal antibody treatment within 4 weeks before the first dose, radiotherapy or small molecule targeted drugs within 2 weeks, or still within the 5 half-lives of the drug (the shortest appearing time shall prevail), the washout period is calculated from the end of the last treatment;
- Received traditional Chinese medicine (including Compound Eschar Capsules, Kangai Injection, Kanglaite Capsules/Injection, Aidi Injection, Yanzaizi Oil Injection/Capsules, Xiaocaiping Tablets/Injection, Huachansu Capsules, etc.) with anti-tumor indications approved by the National Medical Products Administration (NMPA) in the drug instructions within 2 weeks before the first dose;
- Previously used other antibody drugs targeting both CD3 and CD20;
- Received Chimeric antigen receptor T (CAR-T) treatment or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose;
- Previously received R-GemOx or GemOx treatment;
- Known allergies to excipient components of the study drug.
- Participated in and used other anti-tumor clinical trial drugs within 4 weeks or 5 half-lives before the first dose.
- In the judgment of the investigator, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the study.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites, 25 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yuqin Song, Doctor, 13683398726, SongYQ_VIP@163.com
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Junfeng Zhu, Master, 15215526662, Zhujunfeng517@163.com
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, Doctor, 13039046656, lbl2054@163.com
- Not yet recruiting
The second Hospital of dalian
Dalian, Liaoning, 116000
Xiuhua Sun, Master, 17709873631, 3038668@vip.sina.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Hongming He, Bachelor, 13799361913, 811488521@qq.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyuan Zhang, Doctor, 13312612989, 13313612989@163.com
- Not yet recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Zengjun Li, Doctor, 13642138692, zengjunli@163.com
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000
Junfeng Jiang, Master, 13893332604, 13893332604@163.com
- Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Qiangqiang Zhao, Doctor, 17377208596, zgxyws@163.com
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Xiaoming Li, Master, 13700986866, Lxm6358@21cn.com
- Recruiting
Maanshan People's Hospital
Ma’anshan, Anhui, 243000
Guanyu Wu, Master, 17755574016, 17755574016@139.com
- Not yet recruiting
Jiangxi Canser Hospital
Nanchang, Jiangxi, 330029
Wuping Li, Doctor, 13870659916, 18907001021@163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Lei Fan, Doctor, 13813976136, fanlei3014@126.com
- Not yet recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Xuejun Guo, Master, 13903930612, zgxyws@163.com
- Recruiting
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
Jianda Hu, Doctor, 13959169016, drjiandahu@163.com
Meiling Li, Doctor, 15880909409, 2189356143@qq.com
- Not yet recruiting
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, 200032
Rong Tao, Doctor, 18121293435, hkutao@hotmail.com
- Not yet recruiting
Shanxi Cancer hospital
Taiyuan, Shanxi, 30000
Liping Su, Doctor, 13835158122, slpsy2022@163.com
- Not yet recruiting
People's Hospital of Tianjin (City)
Tianjin, Tianjin Municipality, 300000
Huaqing Wang, Doctor, 18622221223, huaqingw@163.com
- Not yet recruiting
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Zhengzi Qian, Doctor, 18622221226, qzz@163.com
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Huijing Wu, Doctor, 13986195042, Wuhuijing8034@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shannxi, 710000
PengCheng He, Doctor, 18991232609, hpec_gcp@163.com
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Zhenyu Li, Doctor, 18052268668, lizhenyumd@163.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 26400
Junjie Ma, Master, 18660487687, mjjshj@sina.com
- Recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 457000
Keshu Zhou, Doctor, 13674902391, drzhouks77@163.com
About this study
Official title: Phase Ib/II Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
To explore the efficacy and safety of TQB2825 injection combined immunochemotherapy in subjects with untreated or R/R DLBCL.
The efficacy evaluation indicators are objective response rate (ORR), complete response rate (CR rate),progression free survival (PFS), duration of response (DOR) and overall survival(OS).
The safety evaluation indicators are dose-limiting toxicity (DLT) , maximum tolerated dose (MTD)and recommended phase II dose (RP2D).
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- TQB2825 injection +R-CHOP regimen, TQB2825 injection + GemOx
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2825 injection +R-CHOP regimenDrug
R-CHOP is a cancer treatment regimen that uses a combination of five drugs to treat non-Hodgkin lymphoma, e.g., Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone (R-CHOP).
TQB2825 Injection: TQB2825 is a bispecific antibody targeting the cluster of differentiation 20 (CD20) receptor on tumor cells and the cluster of differentiation 3 (CD3) receptor on T cells.
Rituximab: A monoclonal antibody that binds to the CD20 antigen on the surface of B cells.
Cyclophosphamide: An alkylating agent that inhibits the synthesis of DNA and proteins in cancer cells.
Doxorubicin Hydrochloride: An antineoplastic antibiotic that inhibits the synthesis of DNA and RNA.
Vincristine: A microtubule inhibitor that blocks the normal function of microtubules during cell division.
Prednisone: A corticosteroid drug with anti-inflammatory, anti-allergic, immunosuppressive, and anti-cancer effects.
TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)
TQB2825 injection + GemOxDrug
TQB2825 Injection: TQB2825 is a bispecific antibody targeting the CD20 receptor on tumor cells and the CD3 receptor on T cells.
Gemcitabine: A nucleoside analog that inhibits DNA synthesis. Oxaliplatin: A platinum-based chemotherapy drug that forms cross-links with DNA, inhibiting DNA replication and transcription.
| Study group | Role | What they receive |
|---|---|---|
| TQB2825 injection +R-CHOP | Experimental | TQB2825 injection+R-CHOP (Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone) TQB2825 injection,Rituximab,Cyclophosphamide,DoxorubicinHydrochloride,Vincristine,Prednisone,21 days as a treatment cycle. Receives: Drug: TQB2825 injection +R-CHOP regimen |
| TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin) | Experimental | TQB2825 injection, Gemcitabine, Oxaliplatin, 21 days as a treatment cycle. Receives: Drug: TQB2825 injection + GemOx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity
The occurrence of one or more unacceptable toxicities after administration, which prevents the increase of dosage or the extension of the dosing interval.
Measured: Baseline to up to two years
Maximum tolerated dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
Measured: Baseline to up to two years
Secondary outcomes (7)
Objective Response Rate (ORR)
ORR: According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune RECIST (iRECIST), the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Measured: Baseline to up to two years
Complete response (CR)
The percentage of subjects achieving complete response (CR) according to the Lugano classification criteria of 2014.
Measured: Baseline to up to two years
Progression-free survival (PFS)
The period from the first use of the drug to disease progression or death (whichever occurs first).
Measured: Baseline to up to two years
Duration of Remission (DOR)
The period from firstly-recorded objective tumor response (CR or PR) to firstly-recorded objective tumor progression or death due to any cause (whichever occurs first) .
Measured: Baseline to up to two years
Overall survival (OS)
From randomization to the time of death from any cause.
Measured: Baseline to up to five years
Incidence and severity of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug.The nature and severity of adverse events were evaluated according to the National Cancer Institute (NCI) standard for common toxicity criteria (CTC) version 5.0 reactions.
Measured: Baseline to up to two years
Incidence of serious adverse events (SAEs)
It refers to adverse medical events such as death, life-threatening, permanent or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.
Measured: Baseline to up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start23 Apr 2025
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829771
- Sponsor's protocol ID
- TQB2825-Ib/II-01
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06829771
- Acronym / sponsor ID
- TQB2825-Ib/II-01
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 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.
To explore the efficacy and safety of TQB2825 injection combined immunochemotherapy in subjects with untreated or R/R DLBCL.
The efficacy evaluation indicators are objective response rate (ORR), complete response rate (CR rate),progression free survival (PFS), duration of response (DOR) and overall survival(OS).
The safety evaluation indicators are dose-limiting toxicity (DLT) , maximum tolerated dose (MTD)and recommended phase II dose (RP2D).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2825 injection +R-CHOP | Experimental | Drug: TQB2825 injection +R-CHOP regimenTQB2825 injection+R-CHOP (Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone) TQB2825 injection,Rituximab,Cyclophosphamide,DoxorubicinHydrochloride,Vincristine,Prednisone,21 days as a treatment cycle. |
| TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin) | Experimental | Drug: TQB2825 injection + GemOxTQB2825 injection, Gemcitabine, Oxaliplatin, 21 days as a treatment cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Age 18 to under 80 years old (calculated from the date of signing the informed consent form);
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
- Life expectancy greater than 12 weeks;
- In the dose expansion phase, previously untreated patients with International Prognostic Index (IPI) scores of 2-5;
Key exclusion criteria (38 listed)
- The subject has had or currently has other malignant tumors that occurred within 5 years before the first dose of the study drug. The following two situations are eligible for enrollment: other malignant tumors that have been treated with single surgery and have achieved continuous 5 years of disease-free survival (DFS); cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane)];
- Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized with hormone replacement therapy, which are deemed to have no safety risks by the investigator;
- Received major surgical treatment, significant traumatic injury within 4 weeks before the first dose, or expected to undergo major surgery during the study treatment period, or has long-term unhealed wounds or fractures;
- Any subject with bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;
- A history of arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, or any other history of serious thromboembolism (thrombosis from implanted venous access ports or catheters, or superficial vein thrombosis is not considered "serious" thromboembolism);
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 |
|---|---|---|
| TQB2825 injection +R-CHOP regimenR-CHOP is a cancer treatment regimen that uses a combination of five drugs to treat non-Hodgkin lymphoma, e.g., Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone (R-CHOP). TQB2825 Injection: TQB2825 is a bispecific antibody targeting the cluster of differentiation 20 (CD20) receptor on tumor cells and the cluster of differentiation 3 (CD3) receptor on T cells. Rituximab: A monoclonal antibody that binds to the CD20 antigen on the surface of B cells. Cyclophosphamide: An alkylating agent that inhibits the synthesis of DNA and proteins in cancer cells. Doxorubicin Hydrochloride: An antineoplastic antibiotic that inhibits the synthesis of DNA and RNA. Vincristine: A microtubule inhibitor that blocks the normal function of microtubules during cell division. Prednisone: A corticosteroid drug with anti-inflammatory, anti-allergic, immunosuppressive, and anti-cancer effects. TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin) | Drug | TQB2825 injection +R-CHOP |
| TQB2825 injection + GemOxTQB2825 Injection: TQB2825 is a bispecific antibody targeting the CD20 receptor on tumor cells and the CD3 receptor on T cells. Gemcitabine: A nucleoside analog that inhibits DNA synthesis. Oxaliplatin: A platinum-based chemotherapy drug that forms cross-links with DNA, inhibiting DNA replication and transcription. | Drug | TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin) |
Primary outcome
Dose Limited Toxicity
Time frame: Baseline to up to two years
The occurrence of one or more unacceptable toxicities after administration, which prevents the increase of dosage or the extension of the dosing interval.
Maximum tolerated dose (MTD)
Time frame: Baseline to up to two years
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Baseline to up to two years
Complete response (CR)
Time frame: Baseline to up to two years
Progression-free survival (PFS)
Time frame: Baseline to up to two years
Duration of Remission (DOR)
Time frame: Baseline to up to two years
Overall survival (OS)
Time frame: Baseline to up to five years
Incidence and severity of adverse events (AEs)
Time frame: Baseline to up to two years
Incidence of serious adverse events (SAEs)
Time frame: Baseline to up to two years
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 Jan 2026.
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Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2825 injection +R-CHOP regimen and TQB2825 injection + GemOx in people with Diffuse Large B Cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 25 sites 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 20 inclusion and 38 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 combined 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.
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 Yuqin Song, Doctor (13683398726, SongYQ_VIP@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity (time frame: Baseline to up to two years). The study lists 2 primary outcomes in all. 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 Jan 2026.