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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection | Experimental | The subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CR rate) | Percentage of subjects with complete (CR) per 2014 Lugano criteria. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Percentage of subjects with complete (CR) or partial response (PR) according to 2014 Lugano Criteria. | 1 year |
| Progression-free survival (PFS) | Time from randomization or first dose to disease progression or death from any cause, whichever occurs first, as determined by the 2014 Lugano Criteria. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who had or currently had other malignant tumors within 5 years prior to the first dose;
Previous or current involvement or suspected involvement of the central nervous system by lymphoma;
Failure to recover from adverse reactions to Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0) criteria ≤ grade 1 from previous treatment;
History of previous anti-tumor treatment:
Subjects who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within 4 weeks prior to the first use of medication, or have long-term untreated wounds or fractures;
Subjects who experience any bleeding or bleeding events ≥ Common Terminology Criteria Adverse Event (CTC AE) grade 3 within 4 weeks prior to the first administration;
Hyperactive/venous thrombotic events within 6 months prior to first dose,Such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism or any other history of severe thromboembolism;
Clinically significant uncontrolled pleural effusion, ascites and more than moderate pericardial effusion requiring repeated drainage;
Decompensated cirrhosis (Child-Pugh class B or C liver function) and active hepatitis;
Pulmonary disease, including any of the following: 1) with or without current pneumonitis requiring corticosteroid therapy; 2) with or suspected chronic obstructive 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, syphilis and tuberculosis.
Unexplained fever > 38.5℃ during screening or before the first dose;
Renal failure requiring hemodialysis or peritoneal dialysis, previous history of nephrotic syndrome;
History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;
Have or have had prior autoimmune disease requiring treatment.
Prepare to undergo or have previously received organ transplantation, or have a significant host transplant response, or have previously received allogeneic hematopoietic stem cell transplantation; 19、Need to receive systemic immunosuppressive 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 5 half-lives before the first dose.
Any condition that, in the judgment of the investigator, would jeopardize the safety of the subject or prevent the subject from completing the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Cai, Doctor | Contact | 13798101121 | caiqq@sysucc.org.cn | |
| Rong Tao, Doctor | Contact | 18121293435 | hkutao@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College | Not yet recruiting | Wuhu | Anhui | 241001 | China |
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|
| 1 year |
| Duration of Response (DOR) | The time from first achievement of response, to disease progression or death from any cause, whichever comes first, was determined according to the 2014 Lugano criteria. | 1 year |
| Time to Response (TTR) | Time from randomization or first dose of trial drug to the first evaluation of PR or CR, whichever occurs first. | 1 year |
| Overall survival (OS) | From randomization to the time of death from any cause. | 3 years |
| Half-life (t1/2) | Time required for the amount of drug in the body or blood concentration to be reduced by half. | Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days |
| Area under the plasma concentration-time curve (AUC0-last) | Area under the dynamic curve of plasma concentration over time. | Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days |
| Apparent clearance (CL) | The rate at which the drug is cleared from the body. | Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days |
| Apparent volume of distribution at terminal phase (Vz) | The volume of body fluid required to distribute the drug in the body according to the plasma drug concentration at this time after the drug distribution in the plasma and tissues has reached equilibrium. | Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days |
| Trough plasma concentration (Cmin) | Maximum blood concentration achieved by drug administration. | Pre-dose, 5 minutes, 24, 72, 120 and 168 hours post dose on day 1 of cycles 2, 4; pre-dose, 5 minutes post dose on day 1 of cycles 3, 8; once at the end of treatment, each cycle is 21 days |
| Anti-drug antibody (ADA ) incidence | Immunogenicity test: Anti-drug antibody (ADA ) incidence. | 2 years |
| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361003 | China |
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| Gansu Provincial Cancer Hospital | Not yet recruiting | Lanzhou | Gansu | 730050 | China |
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| Affiliated Cancer Hospital and insititute Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510095 | China |
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| Guangxi Medical University Cancer Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Hubei Cancer Hospital (HBCH) | Not yet recruiting | Wuhan | Hubei | 430079 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 434000 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215006 | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | 330029 | China |
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| The Second Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116000 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
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| Shandong cancer hospital | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Weihai Central Hospital | Not yet recruiting | Weihai | Shandong | 264499 | China |
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| Shanxi Provincial Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
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| Sichuan Provincal People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| THE First Affiliated Hospital ZheJiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D007267 | Injections |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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