Actively Recruiting
A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-12-11
42
Participants Needed
14
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Age between 18 and 75 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2
- Expected survival greater than 12 weeks
- Confirmed diagnosis of multiple myeloma meeting International Myeloma Working Group Relapsed criteria
- Presence of measurable lesions
- Refractory multiple myeloma after at least one line of treatment including proteasome inhibitor, immunomodulator, and CD38 monoclonal antibody
- Disease progression within 12 months after last treatment
- Laboratory tests meeting study requirements
- Women of childbearing age agree to use effective contraception during the study and for 6 months after, with negative pregnancy test within 7 days before enrollment
- Men agree to use effective contraception for 6 months after the study period
You will not qualify if you...
- Diagnosis of amyloidosis, active plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or other plasma cell tumors
- Allogeneic hematopoietic stem cell transplant within 1 year or autologous hematopoietic stem cell transplant within 12 weeks before first medication
- Known or suspected invasion of meninges or central nervous system
- Previous treatment with CD3×BCMA dual antibody therapy
- High cumulative dose of dexamethasone or other glucocorticoids within 4 weeks before first medication
- Recent targeted therapy, cytotoxic drugs, antibody therapy, proteasome inhibitors, radiotherapy, or immunomodulatory therapy within specified timeframes before first medication
- Recent use of Chinese patent medicines with anti-tumor effects within 2 weeks before first medication
- History of live attenuated vaccination within 4 weeks before first medication or planned vaccination during study
- History of severe allergies to monoclonal antibodies, human immunoglobulin, TQB2934, or its ingredients
- Other malignant tumors within past 3 years or currently
- Unresolved toxic reactions above grade 1 from previous treatments (except hair loss, fatigue, peripheral neuropathy)
- Major surgery, traumatic injury, or ongoing wound/fracture within 4 weeks before first medication
- Arterial or venous thrombosis within 6 months before first dose
- History of psychotropic substance abuse, untreated mental disorders, epilepsy requiring treatment
- Poor blood pressure or diabetes control
- Active or uncontrolled severe infections within 4 weeks before first medication
- Hepatitis or decompensated cirrhosis
- Active tuberculosis or certain lung diseases needing treatment
- Asthma within 2 years or chronic obstructive pulmonary disease with low lung function
- Major cardiovascular diseases
- History of immunodeficiency
- Any other conditions that may risk safety or study completion as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 519041
Not Yet Recruiting
4
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China, 67000
Not Yet Recruiting
5
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
6
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
7
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
8
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Not Yet Recruiting
9
Nanchang University First Affiliated Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
10
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
11
Heze Municipal Hospital
Heze, Shandong, China, 27400
Not Yet Recruiting
12
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
13
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
14
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300192
Not Yet Recruiting
Research Team
P
Peng Liu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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