Actively Recruiting
Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-03-24
55
Participants Needed
24
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent with good compliance
- Age 18 years or older at informed consent
- Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
- Expected survival longer than 12 weeks
- Histological or cytological diagnosis of diffuse large B-cell lymphoma per WHO 2022 criteria
- Pathological diagnosis showing CD20 positive expression and negative Myc rearrangement after anti-CD20 treatment
- Relapsed or refractory diffuse large B-cell lymphoma with at least one prior systemic therapy
- Not suitable for hematopoietic stem cell transplantation
- At least one measurable lesion by CT or PET-CT per Lugano 2014 criteria
- Laboratory tests meet specific study requirements
- Use of effective contraceptive measures
You will not qualify if you...
- History of other malignant tumors within 5 years before first dose
- Previous or current central nervous system involvement or suspected lymphoma involvement
- Unrecovered adverse reactions greater than grade 1 from prior treatment per CTCAEv5.0
- Prior use of other CD3 and CD20 bispecific antibody drugs
- Received CAR-T, other immune cell therapy, or autologous stem cell transplant within 3 months before first dose
- Prior treatment with R-GemOx or GemOx
- More than 4 prior chemotherapy or immunotherapy treatments, or more than 2 radiotherapy or small molecule targeted treatments
- Use of anti-tumor Chinese patent medicines more than twice before first dose
- Major surgery, significant trauma, or untreated wounds/fractures within 4 weeks before first medication
- Recent bleeding events grade 3 or higher within 4 weeks before first administration
- Recent severe thromboembolic events within 6 months before first dose
- Clinically significant uncontrolled pleural effusion, ascites, or moderate/severe pericardial effusion
- Decompensated cirrhosis or active hepatitis
- Pulmonary disease including pneumonitis requiring steroids or COPD with FEV1 less than 60%
- Brain or mental disorders
- Major cardiovascular disease
- Active or uncontrolled infection grade 2 or higher including pneumonia, syphilis, tuberculosis
- Unexplained fever over 38.5°C during screening or before first dose
- Renal failure requiring dialysis or history of nephrotic syndrome
- History of immunodeficiency including HIV or congenital/acquired immune diseases
- Prior or current autoimmune disease requiring treatment
- Planned or previous organ transplantation or allogeneic stem cell transplantation
- Need for systemic immunosuppressive therapy
- Known or suspected hemophagocytic syndrome
- Known allergy to study drug components
- Participation in other anti-tumor trials within washout periods
- Any condition that might endanger safety or study completion in investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China, 241001
Not Yet Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
3
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
4
Affiliated Cancer Hospital and insititute Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Not Yet Recruiting
5
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
6
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Not Yet Recruiting
7
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
9
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
10
Hubei Cancer Hospital (HBCH)
Wuhan, Hubei, China, 430079
Not Yet Recruiting
11
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 434000
Not Yet Recruiting
12
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
13
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
14
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
15
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
16
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
17
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China, 116000
Actively Recruiting
18
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
19
Shandong cancer hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
20
Weihai Central Hospital
Weihai, Shandong, China, 264499
Not Yet Recruiting
21
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
22
Sichuan Provincal People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
23
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
24
THE First Affiliated Hospital ZheJiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
Research Team
Q
Qingqing Cai, Doctor
CONTACT
R
Rong Tao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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