Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients

Exclusion Criteria

• •Diagnosed with other types of amyloidosis, active plasma cell leukemia, active multiple myeloma, etc.
• •Have received allogeneic hematopoietic stem cell transplantation within 1 year prior to the first dose, or have received autologous hematopoietic stem cell transplantation within 12 weeks prior to the first dose;
• •Previously received treatment with drugs targeting the same target;
• •Within 4 weeks prior to the first dose, the patient has received a cumulative dose of dexamethasone \>160 mg or an equivalent dose of other glucocorticoids, or within 3 weeks prior to the first dose, the patient has received targeted therapy, cytotoxic drugs, or any antibody therapy, or within 2 weeks prior to the first dose, the patient has received proteasome inhibitor therapy or radiotherapy, or within 1 week prior to the first dose, the patient has received immunomodulator therapy;
• •Those who have received treatment with traditional Chinese patent medicines and simple preparations with clear anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 weeks before the first administration;
• •Those who have received attenuated live vaccine within 4 weeks before the first dose or plan to receive attenuated live vaccine during the study period;
• •Individuals with a history of severe allergies of unknown cause, or known allergies to monoclonal antibody drugs or exogenous human immunoglobulins, or known allergies to the excipients in injectable TQB2934 or pharmaceutical preparations;
• •Having had or currently suffering from other malignant tumors within 3 years before the first medication;
• •Unresolved toxic reactions above Common Terminology Criteria (CTC) AE Grade 1 caused by any previous treatment;
• •Those who have undergone major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the study treatment period within 4 weeks before the first dose of medication;
• •Arterial/venous thromboembolic events occurred within 6 months before the first dose;
• •Individuals with a history of abuse of psychotropic drugs who are unable to quit or who have mental disorders; or intractable seizures that require treatment;
• •Those with unsatisfactory blood pressure control;
• •Patients with poorly controlled diabetes;
• •Patients who have active or uncontrolled severe bacterial, viral, or systemic fungal infections (≥CTC AE Grade 2 infections) within 4 weeks before the first dose of medication;
• •Patients with hepatitis or decompensated liver cirrhosis (Child-Pugh Class B or C);
• •Individuals with active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or clinically symptomatic active pneumonia;
• •Those who have experienced asthma within 2 years before the first medication or currently suffer from asthma or chronic obstructive pulmonary disease;
• •Individuals with significant cardiovascular diseases;
• •Individuals with a history of immune deficiency, or active autoimmune diseases requiring systemic immunosuppressive therapy, etc.
• •Exclude subjects with organ failure unrelated to systemic light-chain (AL) amyloidosis;
• •Subjects deemed unsuitable for enrollment by the researchers.