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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
TQB2934 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.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGNanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
NOT_YET_RECRUITINGNorth China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
NOT_YET_RECRUITINGNanjing Drum Tower hospital
Nanjing, Jiangsu, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGNanchang University First Affiliated Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITING...and 4 more locations
Peak time (Tmax)
It refers to the time when TQB2934 (subcutaneous injection) is administered for injection to reach the maximum blood drug concentration.
Time frame: Within 120 hours after administration
Peak drug concentration (Cmax)
It refers to the highest blood drug concentration after administration of TQB2934 (subcutaneous injection).
Time frame: Within 120 hours after administration
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.
Time frame: Within 120 hours after administration
Elimination half-life (t1/2)
t1/2 is time it takes for the blood concentration of TQB2934 to drop by half.
Time frame: Within 120 hours after administration
Apparent clearance (CL)
Apparent clearance (CL)
Time frame: Within 120 hours after administration
Adverse events(AEs)
Incidence and severity of subjects with adverse events(AEs), Abnormal laboratory test value and serious adverse events
Time frame: Up to 24 months
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)
Time frame: Up to 24 months
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)
Time frame: Up to 24 months
very good partial response rate (VGPR)
Proportion of subjects whose best response is VGPR, CR, sCR;
Time frame: Up to 24 months
Complete Response (CR) Rate
Proportion of subjects whose best response is CR
Time frame: Up to 24 months
Strict Complete Response (sCR)
Proportion of subjects whose best response is sCR;
Time frame: Up to 24 months
Negative rate of minimal residual disease (MRD)
The proportion of subjects with negative MRD (\<10-5, multicolor flow cytometry or next-generation sequencing) at any time point from the first administration of the trial drug to disease progression or before receiving new anti-tumor therapy;
Time frame: Up to 24 months
Duration of remission (DOR)
For all subjects whose best response was PR, VGPR, CR, sCR, the time from the date of first achieving PR, VGPR, CR, sCR to the date of first definite disease progression or (any cause) death(whichever occurs first).
Time frame: Up to 24 months
Time to first remission (TTR)
Among all the subjects whose best response is PR, VGPR, CR, sCR, the time from the first administration of the test drug to the date of the first PR and above remission.
Time frame: Up to 24 months
Progression-free survival (PFS)
The time between the first dose of the trial drug and the date of first definite disease progression or death (from any cause), whichever occurs first.
Time frame: Up to 24 months
Overall survival (OS)
Time from first dose of study drug to date of death from any cause.
Time frame: Up to 24 months
Antidrug antibody (ADA) incidence and changes over time
Positive incidence of anti-drug antibodies and changes over time
Time frame: Up to 24 months
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