Phase Ib/II Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;

• Age 18 to under 80 years old (calculated from the date of signing the informed consent form);

• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;

• Life expectancy greater than 12 weeks;

• In the dose expansion phase, previously untreated patients with International Prognostic Index (IPI) scores of 2-5;

• A confirmed diagnosis of diffuse large B-cell lymphoma or grade 3b follicular lymphoma, in accordance with the 2022 World Health Organization (WHO) diagnostic criteria, based on histology or cytology (including diffuse large B-cell lymphoma-not otherwise specified and transformed from indolent lymphomas, not allowing for the following types or components: double-hit, triple-hit, or high-grade B-cell lymphoma-not otherwise specified, mediastinal large B-cell lymphoma, T/histiocyte-rich large B-cell lymphoma, human herpesvirus 8 (HHV8)-positive/primary effusion lymphoma, Anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma, Burkitt's lymphoma, and Hodgkin's lymphoma, etc.);

• Immunophenotypic analysis shows that the tumor is CD20 positive;

• Previous treatment meets the following criteria:

‣ Combined with R-CHOP patients: previously untreated diffuse large B-cell lymphoma patients, allowing for corticosteroid pre-treatment (with or without vincristine) or non-curative palliative local radiotherapy.

⁃ Combined with GemOx patients: patients with diffuse large B-cell lymphoma who have received at least one line of systemic treatment (including at least one line with CD20 monoclonal antibody) and are not suitable for hematopoietic stem cell transplantation or have failed treatment after transplantation or relapsed, and whose disease progressed during the most recent treatment or relapsed after completion of treatment or confirmed no objective response after adequate treatment.

• According to the 2014 Lugano criteria, there is at least one measurable lesion, i.e., lymph node lesions with a long diameter \>15 mm or extranodal lesions with a long diameter \>10 mm based on CT cross-sectional imaging; Positron emission tomography (PET)-computed tomography (CT) scan shows PET positivity;

• Laboratory tests meet the following criteria (not corrected with blood transfusion or hematopoietic growth factors within 14 days before screening):

‣ Hemoglobin (HGB) ≥80g/L;

⁃ Absolute neutrophil count (NEUT) ≥1.0×10∧9/L;

⁃ Platelet count (PLT) ≥ 75×10∧9/L (if accompanied by bone marrow invasion, platelets ≥50×10∧9/L).

⁃ Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);

⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ULN. If accompanied by liver metastasis, then ALT and AST ≤ 5 ULN;

⁃ Serum creatinine (CR) ≤ 1.5 ULN or estimated glomerular filtration rate ≥50 ml/min by the Cockcroft-Gault formula.

⁃ Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (not on anticoagulant therapy);

• Women of childbearing age must agree to use effective contraceptive measures during the study and for 12 months after the study ends, with a negative serum or urine pregnancy test within 7 days before study enrollment; men must agree to use effective contraceptive measures during the study and for 12 months after the study ends.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The second Hospital of dalian
NOT_YET_RECRUITING
Dalian
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Affiliated Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Gansu Provincial Cancer Hospital
NOT_YET_RECRUITING
Lanzhou
Liuzhou People's Hospital
NOT_YET_RECRUITING
Liuzhou
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITING
Luzhou
Maanshan People's Hospital
RECRUITING
Ma’anshan
Jiangxi Canser Hospital
NOT_YET_RECRUITING
Nanchang
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING
Nanjing
Puyang Oilfield General Hospital
NOT_YET_RECRUITING
Puyang
The Second Affiliated Hospital of Fujian Medical University
RECRUITING
Quanzhou
Fudan university shanghai cancer center
NOT_YET_RECRUITING
Shanghai
Shanxi Cancer hospital
NOT_YET_RECRUITING
Taiyuan
People's Hospital of Tianjin (City)
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Cancer Hospital
NOT_YET_RECRUITING
Tianjin
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiao Tong University
NOT_YET_RECRUITING
Xi'an
The Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Yuqin Song, Doctor
SongYQ_VIP@163.com
13683398726
Time Frame
Start Date: 2025-04-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 150
Treatments
Experimental: TQB2825 injection +R-CHOP
TQB2825 injection+R-CHOP (Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone) TQB2825 injection,Rituximab,Cyclophosphamide,DoxorubicinHydrochloride,Vincristine,Prednisone,21 days as a treatment cycle.
Experimental: TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)
TQB2825 injection, Gemcitabine, Oxaliplatin, 21 days as a treatment cycle.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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