Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Diffuse Large B-cell Lymphoma

Last updated: March 19, 2025
Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection

Clinical Study ID

NCT06854445
TQB2825-II-01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 accordancewith the World Health Organization (WHO) diagnostic criteria in 2022;

  • Pathological diagnosis results containing CD20 positive expression and Mycrearrangement negative after anti-CD20 treatment must be provided;

  • Subjects with relapsed or refractory diffuse large B-cell lymphoma who have receivedat 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 > 10mm 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;

Exclusion

Exclusion Criteria:

  • Subjects who had or currently had other malignant tumors within 5 years prior to thefirst dose;

  • Previous or current involvement or suspected involvement of the central nervoussystem by lymphoma;

  • Failure to recover from adverse reactions to Common Terminology Criteria for AdverseEvents version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;

  • History of previous anti-tumor treatment:

  1. previous use of other antibody drugs targeting CD3 and CD20 at the same time;

  2. received Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy, orother immune cell therapy, or autologous hematopoietic stem celltransplantation (auto-HSCT) within 3 months before the first dose;

  3. previous treatment with R-GemOx or GemOx;

  4. received chemotherapy, immunotherapy, monoclonal antibody therapy 4 timesbefore the first dose, 2 times received radiotherapy or small molecule targeteddrugs, or subjects who are still within 5 half-lives of the drug, the washoutperiod is calculated from the end time of treatment;

  5. received treatment with Chinese patent medicines with clear anti-tumorindications 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 tothe first use of medication, or have long-term untreated wounds or fractures;

  • Subjects who experience any bleeding or bleeding events ≥ Common TerminologyCriteria Adverse Event (CTC AE) grade 3 within 4 weeks prior to the firstadministration;

  • Hyperactive/venous thrombotic events within 6 months prior to first dose,Such ascerebrovascular accident (including transient ischemic attack), deep venousthrombosis and pulmonary embolism or any other history of severe thromboembolism;

  • Clinically significant uncontrolled pleural effusion, ascites and more than moderatepericardial effusion requiring repeated drainage;

  • Decompensated cirrhosis (Child-Pugh class B or C liver function) and activehepatitis;

  • Pulmonary disease, including any of the following: 1) with or without currentpneumonitis requiring corticosteroid therapy; 2) with or suspected chronicobstructive pulmonary disease (COPD), and forced expiratory volume in 1 second (FEV1) < 60% (predicted);

  • Brain or mental disorders;

  • Have major cardiovascular disease;

  • Active or uncontrolled infection (≥ CTCAE grade 2 infection), including bacterial,fungal or viral infections including but not limited to active pneumonia, syphilisand tuberculosis.

  • Unexplained fever > 38.5℃ during screening or before the first dose;

  • Renal failure requiring hemodialysis or peritoneal dialysis, previous history ofnephrotic syndrome;

  • History of immunodeficiency, including HIV-positive or other acquired, congenitalimmunodeficiency diseases;

  • Have or have had prior autoimmune disease requiring treatment.

  • Prepare to undergo or have previously received organ transplantation, or have asignificant host transplant response, or have previously received allogeneichematopoietic stem cell transplantation; 19、Need to receive systemicimmunosuppressive therapy;

  • Known or suspected history of hemophagocytic syndrome (HLH);

  • Known hypersensitivity to excipient components of the study drug.

  • Subjects who participated in other anti-tumor clinical trials within 4 or 5half-lives before the first dose.

  • Any condition that, in the judgment of the investigator, would jeopardize the safetyof the subject or prevent the subject from completing the study.

Study Design

Total Participants: 55
Treatment Group(s): 1
Primary Treatment: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
Phase: 2
Study Start date:
March 12, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui 241001
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu 730050
    China

    Site Not Available

  • Affiliated Cancer Hospital and insititute Guangzhou Medical University

    Guangzhou, Guangdong 510095
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050011
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Hubei Cancer Hospital (HBCH)

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 434000
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410000
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi 330029
    China

    Site Not Available

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi 710061
    China

    Site Not Available

  • Shandong cancer hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Weihai Central Hospital

    Weihai, Shandong 264499
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Sichuan Provincal People's Hospital

    Chengdu, Sichuan 610072
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Site Not Available

  • THE First Affiliated Hospital ZheJiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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