Actively Recruiting
Phase 1 Study of Subcutaneous TQB2934 Injection for Treating Malignant Plasma Cell Tumors Including Multiple Myeloma
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-12-11
42
Participants Needed
14
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the bodys handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.
CONDITIONS
Brief Title
A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Signed informed consent and good compliance
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival longer than 12 weeks
- Diagnosed with multiple myeloma according to International Myeloma Working Group criteria
- Presence of measurable lesions
- Refractory multiple myeloma after at least one prior therapy including a proteasome inhibitor, an immunomodulator, and a CD38 monoclonal antibody
- Disease progression within 12 months after last treatment
- Laboratory tests meeting study requirements
- Women of childbearing potential must agree to use effective contraception during and for 6 months after the study; men must also agree to use contraception during this period
You will not qualify if you...
- Diagnosis of amyloidosis, active plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or other plasma cell tumors
- Received allogeneic stem cell transplant within 1 year or autologous stem cell transplant within 12 weeks before the first dose
- Known or suspected central nervous system or meningeal involvement
- Previous treatment with CD3×BCMA dual antibody
- Recent high-dose steroids, targeted therapy, chemotherapy, antibody therapy, proteasome inhibitors, radiotherapy, or immunomodulatory therapy within specified timeframes before first dose
- Use of Chinese patent medicines with anti-tumor effects within 2 weeks before first dose
- Recent live attenuated vaccination within 4 weeks before first dose or planned during the study
- History of severe allergies to monoclonal antibodies, immunoglobulin, TQB2934, or drug excipients
- Current or recent other cancers within 3 years
- Unresolved toxicities above grade 1 from previous treatments (except hair loss, fatigue, neuropathy)
- Recent major surgery, trauma, or wounds within 4 weeks before first dose
- Arterial or venous thrombosis within 6 months before first dose
- History of substance abuse, uncontrolled mental disorders, or epilepsy requiring treatment
- Poorly controlled blood pressure or diabetes
- Active or uncontrolled infections including bacterial, viral, or fungal within 4 weeks before first dose
- Hepatitis or decompensated liver cirrhosis
- Active tuberculosis or certain lung diseases requiring treatment
- Asthma within 2 years before first dose or chronic obstructive pulmonary disease with low lung function
- Major cardiovascular diseases
- History of immunodeficiency
- Other serious diseases or conditions judged by the investigator to affect safety or study completion
Research Team
P
Peng Liu, Doctor
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