Combining TQB2825 Injection with Chemotherapy for 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

This study is testing if adding a new injection called TQB2825 to standard chemotherapy can help adults with diffuse large B-cell lymphoma feel better and improve their treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, Chimeric Antigen Receptor, chemotherapy, Immunotherapy
• Locations: 24 sites (Wuhu, Anhui and 23 other locations)
• Trial ID: NCT06854445 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of TQB2825 injection when used alongside standard chemotherapy agents, Gemcitabine and Oxaliplatin, in patients diagnosed with diffuse large B-cell lymphoma. Participants must be adults with a confirmed diagnosis and measurable disease, who have previously undergone at least one line of systemic therapy. The study aims to determine the preliminary efficacy of this combination treatment in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory diffuse large B-cell lymphoma who have received prior systemic therapy.

Not a fit: Patients who are not suitable for hematopoietic stem cell transplantation or those without measurable lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with diffuse large B-cell lymphoma, potentially improving survival rates.

How similar studies have performed: While this approach is being explored, similar studies combining targeted therapies with chemotherapy have shown promise, indicating potential for success.

Eligibility criteria

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 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;

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:

  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, or other immune cell therapy, or autologous hematopoietic stem cell transplantation (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 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;
  5. 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.

Where this trial is running

Wuhu, Anhui and 23 other locations

• The First Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• Affiliated Cancer Hospital and insititute Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hubei Cancer Hospital (HBCH) — Wuhan, Hubei, China (Not_yet_recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Shandong cancer hospital — Jinan, Shandong, China (Not_yet_recruiting)
• Weihai Central Hospital — Weihai, Shandong, China (Not_yet_recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Sichuan Provincal People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
• THE First Affiliated Hospital ZheJiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qingqing Cai, Doctor

Conditions Diffuse Large Cell B-lymphoma