A Clinical Trial of TQB2934 for Injection in Multiple Myeloma Subjects

Study Purpose

TQB2934 is an anti-CD3(Early T Cell Marker)×BCMA (B cell maturation antigen) 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 is planned for the treatment of patients with multiple myeloma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - The subjects volunteered to join the study and signed informed consent form (ICF)with good compliance; - Age: ≥ 18 years old (when signing ICF); ECOG PS score: 0-1; The expected survival period is more than 3 months; - Multiple myeloma with diagnostic records and meeting the IMWG diagnostic criteria; - In the presence of measurable lesions, at least one of the following criteria must be met: 1.
Serum monoclonal immunoglobulin (M protein)≥1.0g/dL,or urine M protein≥200mg/24h; 2. Light chain type: serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL, and the ratio of free light chain serum immunoglobulin κ and λ is abnormal;
  • - Relapsed or refractory multiple myeloma who have received at least 1 line of therapy in the past, and are refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulator (IMiD) and 1 CD38 monoclonal antibody; - Disease progression during or within 12 months after the last treatment (meeting the PD criteria of IMWG), including refractory or no remission of the last treatment (≥1 cycle) or disease progression within 6 months; - Major organ function is good; - Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7 days before study enrollment;

    Exclusion Criteria:

    - Comorbidities and medical history: 1.
Other malignant tumors have occurred or are currently suffering from other malignant tumors within 3 years before the first medication. 2. Unresolved toxic reactions higher than CTC AE grade 1 or higher due to any previous treatment, excluding alopecia, fatigue and peripheral neuropathy; 3. Major surgical intervention, open biopsy, or significant traumatic injury within 28 days prior to first dose; 4. long-term unhealed wounds or fractures; 5. Hyperactive/venous thrombosis events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; 6. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 7. Subjects with any severe and/or uncontrolled disease,include: 1. Unsatisfactory blood pressure control (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, at least 2 measurements at intervals of more than 24 hours); 2. Myocardial infarction, unstable angina, CTC AE ≥ grade 2 stable angina, ≥ grade 2 heart failure (New York Heart Association (NYHA) classification), ≥ grade 2 arrhythmia occurred within 6 months before the first medication; 3. Cardiac ultrasound evaluation: left ventricular ejection fraction (LVEF) <50%; 4. Active or uncontrolled severe bacterial, viral or systemic fungal infection within 28 days before the first dose (≥CTC AE grade 2 infection); 5. Hepatitis (meeting one of the following criteria: hepatitis B: HBV DNA detection value exceeds the upper limit of normal value; hepatitis C: HCV RNA detection value exceeds the upper limit of normal value) or decompensated cirrhosis (Child-Pugh grade B, C grade; 6. Chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) <60% of predicted value. 7. Has developed or currently suffered from asthma within 2 years before the first medication; 8. A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of solid organ transplantation (except corneal transplantation), and active or autoimmune patients who need to receive systemic immunosuppressant therapy; 9. Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L); 10. Suffering from epilepsy and needing treatment;
  • - Tumor-related symptoms and treatment: 1.
Diagnosed with amyloidosis, plasma cell leukemia (PCL, peripheral plasma cell ratio ≥ 20%, or absolute plasma cell count ≥ 2×109/L), Waldenstrom macroglobulinemia (WM) or POEMS syndrome; 2. Known multiple myeloma meningeal or central nervous system invasion or highly suspected meningeal or central nervous system invasion but cannot be identified; 3. Previously received BCMA-targeted therapy; 4. Previously received allogeneic hematopoietic stem cell transplantation or chimeric antigen receptor T (CAR-T), CAR-NK cell therapy; or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks before the first drug; 5. Received targeted therapy, cytotoxic drugs or any antibody therapy within 3 weeks before the first medication; received proteasome inhibitor therapy or radiotherapy within 2 weeks before the first medication; received immunomodulator therapy within 1 week before the first medication.(Prophylaxis to prevent infusion-related reactions prior to study drug administration)(Calculate the washout period from the end of the last treatment);
  • - research treatment related: 1.
History of live attenuated vaccine vaccination within 28 days before the first dose or planned live attenuated live vaccine vaccination during the study; 2. Unexplained severe allergy history, known allergy to monoclonal antibody drugs or exogenous human immunoglobulin, or known allergy to TQB2934 for injection or excipients in pharmaceutical preparations; - Those who have participated in other anti-tumor drug clinical trials within 4 weeks before the first drug use or have not exceeded 5 drug half-lives; - According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons;

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions


Experimental: TQB2934 injection

intravenous injection. 0.09mg, 0.36 mg, 1mg, 2mg, 3mg, 5mg, 6mg, 10mg, 12mg, 16mg, 20mg each time. once a week in Cycle 1-3. once every 2 weeks in Cycle 4-6. if reach PR and above remission after 6 cycles of administration, once every 4 weeks,28 days as a treatment cycle.


Drug: - TQB2934 injection

TQB2934 is an anti-CD3×BCMA double-specific antibody,which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Peking Union Medical College Hospital, Beijing, Beijing, China




Peking Union Medical College Hospital

Beijing, Beijing, 100032

Site Contact

Junling Zhuang, Doctor


+86 (010) 88068210

Sun Yat-Sen University Cancer Canter, Guangzhou, Guangdong, China




Sun Yat-Sen University Cancer Canter

Guangzhou, Guangdong, 510060

Site Contact

Zhongjun Xia, Master


+86 13602713223

The Henan Cancer Hospital, Zhengzhou, Henan, China




The Henan Cancer Hospital

Zhengzhou, Henan, 450008

Site Contact

Baijun Fang, Doctor



Suzhou, Jiangsu, China




The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000

Site Contact

Bingzong Li, Doctor



Jinan, Shandong, China




Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, 250117

Site Contact

Zengjun Li, Doctor



Zhongshan Hospital of Fudan University, Shanghai, Shanghai, China




Zhongshan Hospital of Fudan University

Shanghai, Shanghai, 200032

Site Contact

Peng Liu, Doctor


+86 (021)60267405

Wenzhou, Zhejiang, China




The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000

Site Contact

Songfu Jiang, Master