A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors
Eligible age
18–75 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
TQB2934 is an anti-Cluster of Differentiation 3 (CD3) (Early T Cell Marker)×B cell maturation antigen (BCMA) double-specific antibody，and the isoform is IgG1(Native Immunoglobulin G1), which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA(B cell maturation antigen) to recruit T cells around BCMA-positive cells, which can activate T cells .Active T cells release granzyme and perforin to kill BCMA-positive target cells. TQB2934 for injection (subcutaneous injection) is intended for the treatment of patients with multiple myeloma.
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
You may qualify if…
- ✓ The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;
- ✓ 18 years old≤age≤75 years old (calculated based on the date of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG) score 0\~2 points; expected survival is greater than 12 weeks;
- ✓ Subjects with multiple myeloma must meet: 1) have a diagnostic record and meet the International Myeloma Working Group Relapsed (IMWG) diagnostic criteria; 2) there is a measurable lesion; 3) Refractory Multiple Myeloma (RRMM) has received at least one line of treatment, and at least one proteasome inhibitor (PI), an immunomodulator (IMiD) and a Cluster of Differentiation 38 (CD38) monoclonal antibody are refractory; 4) disease progression within 12 months after the last treatment or treatment;
- ✓ Laboratory inspection standards that meet the program requirements;
- ✓ Women of childbearing age should agree that effective contraception must be adopted during the study period and within 6 months after the end of the study, and that serum or urine pregnancy tests will be negative within 7 days before the study enrollment; men should agree that effective contraception must be adopted within 6 months after the end of the study period;
You may not qualify if…
- ✕ Diagnosed with amyloidosis, active plasma cell leukemia (PCL, peripheral plasma cell proportion ≥5%, or absolute peripheral plasma cell count ≥0.5×109/L), Fahrenheit macroglobulinemia (WM) or POEMS syndrome and other plasma cell tumors;
- ✕ Have received allogeneic hematopoietic stem cell transplantation within 1 year before the first medication, or have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks before the first medication;
- ✕ Those who are known to have invasion of meninges or central nervous system or are highly suspected of invasion of meninges or central nervous system but cannot be identified;
- ✕ Have received CD3×BCMA dual anti-anti-treatment in the past;
- ✕ Cumulative treatment of dexamethasone \>160 mg or equivalent dose of other glucocorticoids within 4 weeks before the first medication, or received targeted therapy, cytotoxic drugs or any antibody therapy within 3 weeks before the first medication, or received proteasome inhibitor therapy or radiotherapy within 2 weeks before the first medication, or received immunomodulatory therapy within 1 week before the first medication;
- ✕ Those who have received Chinese patent medicine treatments within 2 weeks before the first medication have received National Medical Products Administration (NMPA) -approved drug instructions that clearly have anti-tumor indications;
- ✕ Those who have a history of live attenuated vaccination within 4 weeks before the first medication or plan to undergo live attenuated vaccination during the study period;
- ✕ A person with a history of severe allergies of unknown causes, or known to be allergic to monoclonal antibody drugs or exogenous human immunoglobulin, or known to be allergic to TQB2934 for injection or excipients in drug preparations;
Source: ClinicalTrials.gov · NCT07179679 · last updated 2025-12-11