Actively Recruiting
Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-01-30
90
Participants Needed
25
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of TQB2825 Injection Combined Immunochemotherapy 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 between 18 and under 80 years
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- Life expectancy greater than 12 weeks
- For dose expansion phase, previously untreated patients with International Prognostic Index (IPI) scores of 2-5
- Confirmed diagnosis of diffuse large B-cell lymphoma or grade 3b follicular lymphoma per 2022 WHO criteria
- Tumor is CD20 positive by immunophenotypic analysis
- For R-CHOP group: previously untreated patients, allowing corticosteroid pre-treatment or non-curative local radiotherapy
- For GemOx group: patients with at least one prior systemic treatment including CD20 antibody, unsuitable for or relapsed after hematopoietic stem cell transplantation
- At least one measurable lesion per 2014 Lugano criteria and PET positivity
- Laboratory values within specified limits for hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine, and coagulation
- Women of childbearing age and men must agree to effective contraception during and 12 months post-study with negative pregnancy test before enrollment
You will not qualify if you...
- History or presence of other malignant tumors within 5 years except certain treated cases and non-invasive cancers
- Unresolved adverse reactions from previous treatments above grade 1 except specific exceptions
- Major surgery or significant injury within 4 weeks before first dose or expected during study
- Bleeding events grade 3 or higher within 4 weeks before first dose
- History of serious thrombotic events within 6 months before first dose
- Clinically significant uncontrollable pleural effusion, ascites, or moderate or greater pericardial effusion
- Decompensated cirrhosis or active hepatitis B or C infection
- Pulmonary diseases including past or present pneumonia requiring steroids or COPD with FEV1 <60%
- Brain or mental disorders including substance abuse, CNS diseases, recent cerebrovascular accidents
- Severe cardiovascular disease including heart failure grade III or higher, significant arrhythmias, recent myocardial infarction, prolonged QT interval, uncontrolled hypertension
- Active or uncontrolled infections including COVID-19
- Renal failure requiring dialysis or history of nephrotic syndrome
- History of immunodeficiency including HIV
- Autoimmune diseases requiring treatment except stable hypothyroidism or type 1 diabetes
- Organ transplantation or allogeneic hematopoietic stem cell transplantation history
- Need for systemic immunosuppressive treatment or recent high-dose glucocorticoids
- Known or suspected hemophagocytic lymphohistiocytosis
- Recent anti-tumor treatments within specified washout periods
- Prior use of antibody drugs targeting both CD3 and CD20
- Prior CAR-T or autologous hematopoietic stem cell transplantation within 3 months
- Prior R-GemOx or GemOx treatment
- Allergies to study drug excipients
- Participation in other anti-tumor drug trials within 4 weeks or 5 half-lives before first dose
- Conditions judged by investigator to endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233000
Not Yet Recruiting
2
Maanshan People's Hospital
Ma’anshan, Anhui, China, 243000
Actively Recruiting
3
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
4
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
5
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362000
Actively Recruiting
6
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
7
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
8
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545006
Not Yet Recruiting
9
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
10
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001
Not Yet Recruiting
11
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China, 457000
Actively Recruiting
12
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
13
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
14
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Not Yet Recruiting
15
Jiangxi Canser Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
16
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
17
The second Hospital of dalian
Dalian, Liaoning, China, 116000
Not Yet Recruiting
18
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
19
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 26400
Not Yet Recruiting
20
Fudan university shanghai cancer center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
21
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shannxi, China, 710000
Not Yet Recruiting
22
Shanxi Cancer hospital
Taiyuan, Shanxi, China, 30000
Not Yet Recruiting
23
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
24
People's Hospital of Tianjin (City)
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
25
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
Research Team
Y
Yuqin Song, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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