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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2934 injection (subcutaneous injection) | Experimental | Subcutaneous injection,40mg.60mg each time,Cycle 1-3, once a week,Cycle 4-6, once every 2 weeks, if reach PR and above remission after 6 cycles of administration, once every 4 weeks,28 days as a treatment cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2934 injection (subcutaneous injection) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak time (Tmax) | It refers to the time when TQB2934 (subcutaneous injection) is administered for injection to reach the maximum blood drug concentration. | Within 120 hours after administration |
| Peak drug concentration (Cmax) | It refers to the highest blood drug concentration after administration of TQB2934 (subcutaneous injection). | 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. | 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. | Within 120 hours after administration |
| Apparent clearance (CL) | Apparent clearance (CL) | 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 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 24 months |
| Clinical benefit rate (CBR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liu, Doctor | Contact | 021-60267405 | Liu.peng@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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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)
| Up to 24 months |
| very good partial response rate (VGPR) | Proportion of subjects whose best response is VGPR, CR, sCR; | Up to 24 months |
| Complete Response (CR) Rate | Proportion of subjects whose best response is CR | Up to 24 months |
| Strict Complete Response (sCR) | Proportion of subjects whose best response is sCR; | 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; | 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). | 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. | 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. | Up to 24 months |
| Overall survival (OS) | Time from first dose of study drug to date of death from any cause. | Up to 24 months |
| Antidrug antibody (ADA) incidence and changes over time | Positive incidence of anti-drug antibodies and changes over time | Up to 24 months |
| Nanfang Hospital, Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 519041 | China |
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| The Affiliated Hospital of Chengde Medical College | Not yet recruiting | Chengde | Hebei | 67000 | China |
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| North China University of Science and Technology Affiliated Hospital | Not yet recruiting | Tangshan | Hebei | 063000 | China |
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| Nanjing Drum Tower hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215000 | China |
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| Nanchang University First Affiliated Hospital | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| Heze Municipal Hospital | Not yet recruiting | Heze | Shandong | 27400 | China |
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| Zhongshan Hospital of Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Affiliated Hospital of North Sichuan Medical College | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
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| Tianjin People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300192 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007279 | Injections, Subcutaneous |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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