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Clinical Trial of TQB2825 Inj...

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

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-12

Study Completion Date

2028-02-29

Brief Summary

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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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Detailed Description

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Conditions

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Diffuse Large Cell B-lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection

The subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection.

Group Type EXPERIMENTAL

TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection

Intervention Type 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.

Interventions

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TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers