What is TQB2825 studying for diffuse large B-cell lymphoma?

TQB2825 is being studied in combination with chemotherapy to assess its effectiveness in treating relapsed or refractory diffuse large B-cell lymphoma. The trial aims to evaluate how well this combination works in patients who have previously received treatment. This study is sponsored by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

Who may be eligible for this diffuse large B-cell lymphoma clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma may be eligible. Participants must have received at least one prior systemic therapy and not be suitable for stem cell transplantation. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this diffuse large B-cell lymphoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs outside of the study procedures.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06854445

Phase 2 Study of TQB2825 Injection with Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma

Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-03-24

Participants Needed

Research Sites

121 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the preliminary effectiveness of TQB2825 combined with chemotherapy in adults with diffuse large B-cell lymphoma that has returned or not responded to previous treatments. This phase II clinical trial focuses on patients who have relapsed or refractory disease and are not suitable for stem cell transplantation, aiming to understand how well this combination works in this group. Participants receive a combination treatment that includes TQB2825 injection, gemcitabine hydrochloride for injection, and oxaliplatin for injection. The treatment cycles last 21 days, with careful monitoring of drug levels and response. The study measures various outcomes such as complete response rate after one year, overall survival up to three years, and other markers related to treatment effectiveness and safety. During the trial, participants undergo regular assessments including scans, laboratory tests, and evaluations of response and side effects. Researchers collect detailed pharmacokinetic data at specific time points during treatment cycles. The study also monitors the presence of anti-drug antibodies over two years. Participants health is observed throughout treatment and follow-up periods to evaluate both the response and safety of the therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Voluntarily agree to participate and sign informed consent with good compliance
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG) score between 0 and 2
Expected survival longer than 12 weeks
Histological or cytological diagnosis of diffuse large B-cell lymphoma per WHO 2022 criteria
Pathology showing CD20 positive expression and Myc rearrangement negative after anti-CD20 treatment
Relapsed or refractory diffuse large B-cell lymphoma with at least one prior systemic therapy
Not suitable for hematopoietic stem cell transplantation
At least one measurable lesion by Lugano criteria (lymph node >15 mm or extranodal lesion >10 mm) with PET-CT positive
Meet specific laboratory test requirements
Use effective contraceptive methods

You will not qualify if you...

History or current diagnosis of other malignant tumors within 5 years before first dose
Central nervous system involvement or suspicion by lymphoma
Not recovered from previous treatment adverse reactions above grade 1 per CTCAE v5.0
Previous use of other CD3 and CD20 targeting antibody drugs simultaneously
Received CAR-T therapy, other immune cell therapy, or autologous hematopoietic stem cell transplant within 3 months before first dose
Prior treatment with R-GemOx or GemOx
Received chemotherapy, immunotherapy, monoclonal antibody therapy 4 or more times before first dose; or radiotherapy or targeted drugs 2 or more times; or within 5 half-lives of prior drugs
Received Chinese patent medicines with anti-tumor indications twice before first dose
Major surgery, significant injury, or planned major surgery within 4 weeks before first dose; or untreated wounds or fractures
Bleeding events grade 3 or higher within 4 weeks before first dose
Recent thrombotic events within 6 months before first dose
Significant uncontrolled pleural effusion, ascites, or moderate or more pericardial effusion requiring drainage
Decompensated cirrhosis or active hepatitis
Pulmonary disease including pneumonitis requiring corticosteroids or COPD with FEV1 less than 60%
Brain or mental disorders
Major cardiovascular disease
Active or uncontrolled infections grade 2 or higher including pneumonia, syphilis, tuberculosis
Unexplained fever above 38.5°C during screening or before first dose
Renal failure requiring dialysis or history of nephrotic syndrome
Immunodeficiency including HIV or other acquired/congenital forms
Prior autoimmune disease requiring treatment
Preparing for or history of organ transplantation or allogeneic hematopoietic stem cell transplantation
Need for systemic immunosuppressive therapy
History or suspicion of hemophagocytic syndrome (HLH)
Known hypersensitivity to study drug components
Participation in other anti-tumor clinical trials within 4 or 5 half-lives before first dose
Any condition judged by investigator to jeopardize safety or study completion

Research Team

Qingqing Cai, Doctor

Rong Tao, Doctor

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Phase 2 Study of TQB2825 Injection with Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria