Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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;

Locations
Other Locations
China
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Provincal People's Hospital
NOT_YET_RECRUITING
Chengdu
The Second Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Affiliated Cancer Hospital and insititute Guangzhou Medical University
NOT_YET_RECRUITING
Guangzhou
THE First Affiliated Hospital ZheJiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Shandong cancer hospital
NOT_YET_RECRUITING
Jinan
Gansu Provincial Cancer Hospital
NOT_YET_RECRUITING
Lanzhou
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITING
Luzhou
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Shanxi Provincial Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Weihai Central Hospital
NOT_YET_RECRUITING
Weihai
Hubei Cancer Hospital (HBCH)
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Wannan Medical College
NOT_YET_RECRUITING
Wuhu
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Qingqing Cai, Doctor
caiqq@sysucc.org.cn
13798101121
Backup
Rong Tao, Doctor
hkutao@hotmail.com
18121293435
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2028-02
Participants
Target number of participants: 55
Treatments
Experimental: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
The subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection.
Sponsors
Leads: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

This content was sourced from clinicaltrials.gov

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