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

March 19, 2025 updated by: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China, 241001
        • Not yet recruiting
        • The First Affiliated Hospital of Wannan Medical College
        • Contact:
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510095
        • Not yet recruiting
        • Affiliated Cancer Hospital and insititute Guangzhou Medical University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Not yet recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450052
        • Not yet recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Not yet recruiting
        • Hubei Cancer Hospital (HBCH)
        • Contact:
      • Wuhan, Hubei, China, 434000
        • Not yet recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410011
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • Not yet recruiting
        • the First Affiliated Hospital of Soochow University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Not yet recruiting
        • Jiangxi Cancer Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital Of Xi'an Jiaotong University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Weihai, Shandong, China, 264499
        • Not yet recruiting
        • Weihai Central Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Not yet recruiting
        • Sichuan Provincal People's Hospital
        • Contact:
      • Luzhou, Sichuan, China, 646000
        • Not yet recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection
The subject received TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate (CR rate)
Time Frame: 1 year
Percentage of subjects with complete (CR) per 2014 Lugano criteria.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 1 year
Percentage of subjects with complete (CR) or partial response (PR) according to 2014 Lugano Criteria.
1 year
Progression-free survival (PFS)
Time Frame: 1 year
Time from randomization or first dose to disease progression or death from any cause, whichever occurs first, as determined by the 2014 Lugano Criteria.
1 year
Duration of Response (DOR)
Time Frame: 1 year
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 Frame: 1 year
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)
Time Frame: 3 years
From randomization to the time of death from any cause.
3 years
Half-life (t1/2)
Time Frame: 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
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)
Time Frame: 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 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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 2 years
Immunogenicity test: Anti-drug antibody (ADA ) incidence.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB2825-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diffuse Large Cell B-lymphoma

Clinical Trials on TQB2825 Injection + Gemcitabine Hydrochloride for Injection + Oxaliplatin for Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe