Diffuse Large Cell B-lymphomaPhase 2NCT06854445
Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma
A Phase 2 study testing TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection in people with Diffuse Large Cell B-lymphoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 24 sites in China.
Trial summary
The purpose of this study is to assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large Cell B-lymphoma
- What is being tested?
- TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 24 sitesChina
- Study dates
- 12 Mar 2025to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Age ≥18 years (calculated from the date of informed consent);
- Eastern Cooperative Oncology Group (ECOG) score 0 ~ 2 points;
- Expected survival greater than 12 weeks;
- Histological or cytological diagnosis of diffuse large B-cell lymphoma in accordance with the World Health Organization (WHO) diagnostic criteria in 2022;
- Pathological diagnosis results containing CD20 positive expression and Myc rearrangement negative after anti-CD20 treatment must be provided;
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- Subjects with relapsed or refractory diffuse large B-cell lymphoma who have received at least 1 line of systemic therapy;
- Not suitable for hematopoietic stem cell transplantation;
- According to the Lugano criteria in 2014, there is at least one measurable lesion, that is, the long diameter of lymph node lesions > 15 mm or extranodal lesions > 10 mm according to CT cross-sectional images; Positron emission tomography - computerized tomography (PET-CT) scan shows PET positive;
- Laboratory tests meet specific criteria;
- Adopt effective contraceptive measures;
Who cannot join
- Subjects who had or currently had other malignant tumors within 5 years prior to the first dose;
- Previous or current involvement or suspected involvement of the central nervous system by lymphoma;
- Failure to recover from adverse reactions to Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;
- History of previous anti-tumor treatment:
- previous use of other antibody drugs targeting CD3 and CD20 at the same time;
- received Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose;
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- previous treatment with R-GemOx or GemOx;
- received chemotherapy, immunotherapy, monoclonal antibody therapy 4 times before the first dose, 2 times received radiotherapy or small molecule targeted drugs, or subjects who are still within 5 half-lives of the drug, the washout period is calculated from the end time of treatment;
- received treatment with Chinese patent medicines with clear anti-tumor indications in the package insert of National Medical Products Administration (NMPA)-approved drugs 2 times before the first dose;
- Subjects who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within 4 weeks prior to the first use of medication, or have long-term untreated wounds or fractures;
- Subjects who experience any bleeding or bleeding events ≥ Common Terminology Criteria Adverse Event (CTC AE) grade 3 within 4 weeks prior to the first administration;
- Hyperactive/venous thrombotic events within 6 months prior to first dose,Such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism or any other history of severe thromboembolism;
- Clinically significant uncontrolled pleural effusion, ascites and more than moderate pericardial effusion requiring repeated drainage;
- Decompensated cirrhosis (Child-Pugh class B or C liver function) and active hepatitis;
- Pulmonary disease, including any of the following: 1) with or without current pneumonitis requiring corticosteroid therapy; 2) with or suspected chronic obstructive pulmonary disease (COPD), and forced expiratory volume in 1 second (FEV1) < 60% (predicted);
- Brain or mental disorders;
- Have major cardiovascular disease;
- Active or uncontrolled infection (≥ CTCAE grade 2 infection), including bacterial, fungal or viral infections including but not limited to active pneumonia, syphilis and tuberculosis.
- Unexplained fever > 38.5℃ during screening or before the first dose;
- Renal failure requiring hemodialysis or peritoneal dialysis, previous history of nephrotic syndrome;
- History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;
- Have or have had prior autoimmune disease requiring treatment.
- Prepare to undergo or have previously received organ transplantation, or have a significant host transplant response, or have previously received allogeneic hematopoietic stem cell transplantation; 19、Need to receive systemic immunosuppressive therapy;
- Known or suspected history of hemophagocytic syndrome (HLH);
- Known hypersensitivity to excipient components of the study drug.
- Subjects who participated in other anti-tumor clinical trials within 4 or 5 half-lives before the first dose.
- Any condition that, in the judgment of the investigator, would jeopardize the safety of the subject or prevent the subject from completing the study.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Yajun Li, Doctor, 19918803330, 19918803330@163.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Jinan Ma, Doctor, 13973192715, majinan2825@126.com
- Not yet recruiting
Sichuan Provincal People's Hospital
Chengdu, Sichuan, 610072
Xiaobing Huang, Doctor, 18981838236, hxb_trial@163.com
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Xiuhua Sun, Master, 17709873631, 3038668@vip.sina.com
- Not yet recruiting
Affiliated Cancer Hospital and insititute Guangzhou Medical University
Guangzhou, Guangdong, 510095
Min Zhou, Doctor, 13729897904, syxzhoumin@163.com
- Not yet recruiting
THE First Affiliated Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, 310000
Hongyan Tong, Doctor, 13958122357, hongyantong@aliyun.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyuan Zhang, Doctor, 13313612989, ns86298333@163.com
- Not yet recruiting
Shandong cancer hospital
Jinan, Shandong, 250117
Zengjun Li, Doctor, 13642138692, zengjunli@163.com
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Junfeng Jiang, Master, 13893332604, 13893332604@163.com
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Xiaoming Li, Master, 13700986866, LXM6358@21.com.cn
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Wuping Li, Doctor, 13870659916, 18907001021@163.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Jingyan Xu, Doctor, 13951969610, xjy1967@sina.com
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Hong Cen, Doctor, 13507711671, cen_hong@163.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Haisheng Liu, Doctor, 13933078299, liuhs78299@163.com
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Caixia Li, Doctor, 13616219570, licaixia@suda.edu.cn
- Not yet recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000
Liping Su, Doctor, 13835158122, slpsy2022@163.com
- Not yet recruiting
Weihai Central Hospital
Weihai, Shandong, 264499
Xiangjun Sun, Master, 13561886329, 943221801@qq.com
- Not yet recruiting
Hubei Cancer Hospital (HBCH)
Wuhan, Hubei, 430079
Huijing Wu, Master, 13986195042, 3269614878@qq.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 434000
Yu Liu, Doctor, 13667148436, 1243869986@qq.com
- Not yet recruiting
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001
Hesheng He, Master, 15255378879, hhsmed2012@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Pengcheng He, Doctor, 18991232609, Hepc_gcp@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Bing Xu, Doctor, 18688900980, xubingzhangjian@126.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Keshu Zhou, Doctor, 13674902391, drzhouks77@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xudong Zhang, Doctor, 13633825183, feverxxd@126.com
About this study
Official title: Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
The purpose of this study is to assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma.
- Conditions
- Diffuse Large Cell B-lymphoma
- Being tested
- TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
- 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 + Gemcitabine Hydrochloride for Injection + Oxaliplatin for InjectionDrug
Drug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection;
Other Name:
Gemcitabine Hydrochloride for Injection, Zefei; Oxaliplatin for Injection, Aihen
TQB2825 injection is Cluster of Differentiation 3 (CD3) and and Cluster of Differentiation 20 (CD20) bispecific antibody; Gemcitabine hydrochloride for injection is a cell cycle-specific antimetabolite; Oxaliplatin for Injection is a platinum chemotherapy drug.
| Study group | Role | What they receive |
|---|---|---|
| TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection | Experimental | The subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection. Receives: Drug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CR rate)
Percentage of subjects with complete (CR) per 2014 Lugano criteria.
Measured: 1 year
Secondary outcomes (11)
Overall response rate (ORR)
Percentage of subjects with complete (CR) or partial response (PR) according to 2014 Lugano Criteria.
Measured: 1 year
Progression-free survival (PFS)
Time from randomization or first dose to disease progression or death from any cause, whichever occurs first, as determined by the 2014 Lugano Criteria.
Measured: 1 year
Duration of Response (DOR)
The time from first achievement of response, to disease progression or death from any cause, whichever comes first, was determined according to the 2014 Lugano criteria.
Measured: 1 year
Time to Response (TTR)
Time from randomization or first dose of trial drug to the first evaluation of PR or CR, whichever occurs first.
Measured: 1 year
Overall survival (OS)
From randomization to the time of death from any cause.
Measured: 3 years
Half-life (t1/2)
Time required for the amount of drug in the body or blood concentration to be reduced by half.
Measured: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Area under the plasma concentration-time curve (AUC0-last)
Area under the dynamic curve of plasma concentration over time.
Measured: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Apparent clearance (CL)
The rate at which the drug is cleared from the body.
Measured: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Apparent volume of distribution at terminal phase (Vz)
The volume of body fluid required to distribute the drug in the body according to the plasma drug concentration at this time after the drug distribution in the plasma and tissues has reached equilibrium.
Measured: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Trough plasma concentration (Cmin)
Maximum blood concentration achieved by drug administration.
Measured: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Anti-drug antibody (ADA ) incidence
Immunogenicity test: Anti-drug antibody (ADA ) incidence.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start12 Mar 2025
- Primary completionOct 2025 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large Cell B-lymphomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854445
- Sponsor's protocol ID
- TQB2825-II-01
- Status last verified
- Nov 2024
- First submitted
- 26 Feb 2025
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06854445
- Acronym / sponsor ID
- TQB2825-II-01
- Conditions
- Diffuse Large Cell B-lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 3 Mar 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 assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection | Experimental | Drug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for InjectionThe subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Age ≥18 years (calculated from the date of informed consent);
- Eastern Cooperative Oncology Group (ECOG) score 0 ~ 2 points;
- Expected survival greater than 12 weeks;
- Histological or cytological diagnosis of diffuse large B-cell lymphoma in accordance with the World Health Organization (WHO) diagnostic criteria in 2022;
Key exclusion criteria (27 listed)
- Subjects who had or currently had other malignant tumors within 5 years prior to the first dose;
- Previous or current involvement or suspected involvement of the central nervous system by lymphoma;
- Failure to recover from adverse reactions to Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;
- History of previous anti-tumor treatment:
- Subjects who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within 4 weeks prior to the first use of medication, or have long-term untreated wounds or fractures;
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 + Gemcitabine Hydrochloride for Injection + Oxaliplatin for InjectionDrug: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection; Other Name: Gemcitabine Hydrochloride for Injection, Zefei; Oxaliplatin for Injection, Aihen TQB2825 injection is Cluster of Differentiation 3 (CD3) and and Cluster of Differentiation 20 (CD20) bispecific antibody; Gemcitabine hydrochloride for injection is a cell cycle-specific antimetabolite; Oxaliplatin for Injection is a platinum chemotherapy drug. | Drug | TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection |
Primary outcome
Complete response rate (CR rate)
Time frame: 1 year
Percentage of subjects with complete (CR) per 2014 Lugano criteria.
11 secondary outcomes
Overall response rate (ORR)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Duration of Response (DOR)
Time frame: 1 year
Time to Response (TTR)
Time frame: 1 year
Overall survival (OS)
Time frame: 3 years
Half-life (t1/2)
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Area under the plasma concentration-time curve (AUC0-last)
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Apparent clearance (CL)
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Apparent volume of distribution at terminal phase (Vz)
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Trough plasma concentration (Cmin)
Time frame: Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days
Anti-drug antibody (ADA ) incidence
Time frame: 2 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 24 Mar 2025.
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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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection in people with Diffuse Large Cell B-lymphoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 24 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 11 inclusion and 27 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 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 Qingqing Cai, Doctor (13798101121, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (CR rate) (time frame: 1 year). 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 24 Mar 2025.