Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma
Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
1 other identifier
interventional
55
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2025
Typical duration for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2025
CompletedFirst Posted
Study publicly available on registry
March 3, 2025
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
ExpectedMarch 24, 2025
November 1, 2024
7 months
February 26, 2025
March 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response rate (CR rate)
Percentage of subjects with complete (CR) per 2014 Lugano criteria.
1 year
Secondary Outcomes (11)
Overall response rate (ORR)
1 year
Progression-free survival (PFS)
1 year
Duration of Response (DOR)
1 year
Time to Response (TTR)
1 year
Overall survival (OS)
3 years
- +6 more secondary outcomes
Study Arms (1)
TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
EXPERIMENTALThe subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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;
You may not qualify if:
- 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;
- 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);
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Affiliated Cancer Hospital and insititute Guangzhou Medical University
Guangzhou, Guangdong, 510095, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hubei Cancer Hospital (HBCH)
Wuhan, Hubei, 430079, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 434000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shandong cancer hospital
Jinan, Shandong, 250117, China
Weihai Central Hospital
Weihai, Shandong, 264499, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000, China
Sichuan Provincal People's Hospital
Chengdu, Sichuan, 610072, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
THE First Affiliated Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2025
First Posted
March 3, 2025
Study Start
March 12, 2025
Primary Completion
October 1, 2025
Study Completion (Estimated)
February 1, 2028
Last Updated
March 24, 2025
Record last verified: 2024-11