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.
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;
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;
Single group
TQB2934 injection (subcutaneous injection)
DrugTQB2934 is an anti-CD3(Early T Cell Marker)×BCMA (B cell maturation antigen)double-specific antibody，and the isoform is Native Immunoglobulin G1 ( IgG1), 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.
Peak time (Tmax)
It refers to the time when TQB2934 (subcutaneous injection) is administered for injection to reach the maximum blood drug concentration.
Peak drug concentration (Cmax)
It refers to the highest blood drug concentration after administration of TQB2934 (subcutaneous injection).
Area under the plasma concentration-time curve (AUC0-last)
To characterize the pharmacokinetics of TQB2934 by assessment of area under the plasma concentration time curve.
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB2934 to drop by half.
Overall response rate (ORR)
Proportion of subjects with best response as Partial relief (PR), Very good partial relief (VGPR), Complete Response (CR), Strict Complete Response (sCR)
Clinical benefit rate (CBR)
Proportion of subjects with best response as Minor relief (MR), PR(Partial relief), VGPR(Very good partial relief), CR (Complete Response), sCR (Strict Complete Response)
very good partial response rate (VGPR)
Proportion of subjects whose best response is VGPR, CR, sCR;
Complete Response (CR) Rate
Proportion of subjects whose best response is CR
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