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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат TQB2825 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.

Первичные конечные точки

• Complete response rate (CR rate) [Срок оценки: 1 year]

Вторичные конечные точки (11)

• Overall response rate (ORR) [Срок оценки: 1 year]
• Progression-free survival (PFS) [Срок оценки: 1 year]
• Duration of Response (DOR) [Срок оценки: 1 year]
• Time to Response (TTR) [Срок оценки: 1 year]
• Overall survival (OS) [Срок оценки: 3 years]
• Half-life (t1/2) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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:

• previous use of other antibody drugs targeting CD3 and CD20 at the same time;
• received Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months before the first dose;
• previous treatment with R-GemOx or GemOx;
• received chemotherapy, immunotherapy, monoclonal antibody therapy 4 times before the first dose, 2 times received radiotherapy or small molecule targeted drugs, or subjects who are still within 5 half-lives of the drug, the washout period is calculated from the end time of treatment;
• received treatment with Chinese patent medicines with clear anti-tumor indications 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 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 24 центра

• The First Affiliated Hospital of Wannan Medical College — Wuhu
• The First Affiliated Hospital of Xiamen University — Xiamen
• Gansu Provincial Cancer Hospital — Lanzhou
• Affiliated Cancer Hospital and insititute Guangzhou Medical University — Гуанчжоу
• Guangxi Medical University Cancer Hospital — Nanning
• The Fourth Hospital of Hebei Medical University — Shijiazhuang
• Harbin Medical University Cancer Hospital — Харбин
• Henan Cancer Hospital — Чжэнчжоу
• … и ещё 16 центров

Идентификаторы

NCT: NCT06854445 · TQB2825-II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗