RecruitingPhase 2NCT06854445

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

Sponsor

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Enrollment

55 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large Cell B-lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug combination — TQB2825 (a bispecific antibody targeting CD3 and CD20) combined with chemotherapy — for people with diffuse large B-cell lymphoma (DLBCL), a fast-growing blood cancer, whose disease has returned or not responded to prior treatment. **You may be eligible if:** - You are 18 years or older - You have relapsed or refractory DLBCL confirmed by biopsy - You have received at least 1 prior treatment - You are not a candidate for stem cell transplant - You have measurable disease on imaging - You have adequate organ function **You may NOT be eligible if:** - You have had another cancer in the past 5 years - Your cancer involves the brain or spinal cord - You have active HIV, hepatitis, or an immune deficiency - You have recently had a blood clot, stroke, or significant bleeding - You have serious heart or lung disease - You have received certain prior treatments including CAR-T cell therapy within 3 months - You have had an organ or bone marrow transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection

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.

Locations(24)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Affiliated Cancer Hospital and insititute Guangzhou Medical University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital (HBCH)

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong cancer hospital

Jinan, Shandong, China

Weihai Central Hospital

Weihai, Shandong, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Sichuan Provincal People's Hospital

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

THE First Affiliated Hospital ZheJiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06854445