A Clinical Trial of TQB2934 for Injection in Multiple Myeloma Subjects

Inclusion Criteria:

• The subjects volunteered to join the study and signed informed consent form (ICF)withgood compliance;
• Age: ≥ 18 years old (when signing ICF); ECOG PS score: 0-1; The expected survivalperiod 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 bemet:

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 theratio of free light chain serum immunoglobulin κ and λ is abnormal;

• Relapsed or refractory multiple myeloma who have received at least 1 line of therapyin the past, and are refractory to at least 1 proteasome inhibitor (PI), 1immunomodulator (IMiD) and 1 CD38 monoclonal antibody;
• Disease progression during or within 12 months after the last treatment (meeting thePD criteria of IMWG), including refractory or no remission of the last treatment (≥1cycle) or disease progression within 6 months;
• Major organ function is good;
• Female subjects of childbearing age should agree to use contraceptive measures (suchas 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 7days before study enrollment;

Exclusion Criteria:

• Comorbidities and medical history:

1. Other malignant tumors have occurred or are currently suffering from othermalignant tumors within 3 years before the first medication.
2. Unresolved toxic reactions higher than CTC AE grade 1 or higher due to anyprevious 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 firstmedication, such as cerebrovascular accidents (including transient ischemicattacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis andpulmonary embolism, etc.;
6. Those who have a history of psychotropic drug abuse and cannot quit or havemental disorders;
7. Subjects with any severe and/or uncontrolled disease,include:
8. Unsatisfactory blood pressure control (systolic blood pressure ≥ 160 mmHg ordiastolic blood pressure ≥ 100 mmHg, at least 2 measurements at intervals ofmore than 24 hours);
9. 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;
10. Cardiac ultrasound evaluation: left ventricular ejection fraction (LVEF) <50%;
11. Active or uncontrolled severe bacterial, viral or systemic fungal infectionwithin 28 days before the first dose (≥CTC AE grade 2 infection);
12. Hepatitis (meeting one of the following criteria: hepatitis B: HBV DNAdetection value exceeds the upper limit of normal value; hepatitis C: HCVRNA detection value exceeds the upper limit of normal value) ordecompensated cirrhosis (Child-Pugh grade B, C grade;
13. Chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) <60% of predicted value.
14. Has developed or currently suffered from asthma within 2 years before thefirst medication;
15. A history of immunodeficiency, including HIV positive or other acquired,congenital immunodeficiency diseases, or a history of solid organtransplantation (except corneal transplantation), and active or autoimmunepatients who need to receive systemic immunosuppressant therapy;
16. Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L);
17. Suffering from epilepsy and needing treatment;

• Tumor-related symptoms and treatment:

1. Diagnosed with amyloidosis, plasma cell leukemia (PCL, peripheral plasma cellratio ≥ 20%, or absolute plasma cell count ≥ 2×109/L), Waldenstrommacroglobulinemia (WM) or POEMS syndrome;
2. Known multiple myeloma meningeal or central nervous system invasion or highlysuspected meningeal or central nervous system invasion but cannot be identified;
3. Previously received BCMA-targeted therapy;
4. Previously received allogeneic hematopoietic stem cell transplantation orchimeric antigen receptor T (CAR-T), CAR-NK cell therapy; or received autologoushematopoietic stem cell transplantation (ASCT) within 12 weeks before the firstdrug;
5. Received targeted therapy, cytotoxic drugs or any antibody therapy within 3 weeksbefore the first medication; received proteasome inhibitor therapy orradiotherapy within 2 weeks before the first medication; received immunomodulatortherapy within 1 week before the first medication.(Prophylaxis to preventinfusion-related reactions prior to study drug administration)(Calculate thewashout period from the end of the last treatment);

• research treatment related:

1. History of live attenuated vaccine vaccination within 28 days before the firstdose or planned live attenuated live vaccine vaccination during the study;
2. Unexplained severe allergy history, known allergy to monoclonal antibody drugs orexogenous human immunoglobulin, or known allergy to TQB2934 for injection orexcipients in pharmaceutical preparations;

• Those who have participated in other anti-tumor drug clinical trials within 4 weeksbefore the first drug use or have not exceeded 5 drug half-lives;
• According to the investigator's judgment, there are concomitant diseases thatseriously endanger the safety of the subjects or affect the completion of the study,or subjects who are considered unsuitable for enrollment for other reasons;