Assessment of the Efficacy and Safety of Injectable TQB29... | NCT07266116

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TQB2934 injection	Experimental	TQB2934 injection 40 mg and 60 mg During cycles 1-3, medication is administered once a week. From the end of cycles 4-6, medication is administered once every two weeks. For patients who have not achieved complete remission (CR) or have MRD positivity after six cycles of medication, medication is administered once every eight weeks, with a maximum treatment duration of no more than two years	Drug: TQB2934 injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TQB2934 injection	Drug	TQB2934 for injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3). One end binds to the CD3 receptor on the surface of T cells, while the other end binds to BCMA, recruiting T cells to BCMA-positive cells. This can activate T cells, which then release granzyme, perforin, and other enzymes to kill BCMA-positive malignant plasma cells, thereby reducing the level of monoclonal immunoglobulin light chains in the body and delaying further organ damage.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of subjects with adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs)	The occurrence of all adverse events (AEs), serious adverse events (SAEs), incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).	Baseline to the end of the study, about 4 years
The best hematological response evaluated by the Independent Review Committee (IRC) is complete remission (CR)	Percentage of subjects who achieved complete hematological remission (CR) after receiving TQB2934 for injection among adult subjects with relapsed/refractory systemic light chain amyloidosis who had previously received treatment with duramycin and bortezomib.	Baseline to CR，about 1.5 years

Secondary Outcomes

Measure	Description	Time Frame
Peak concentration (Cmax)	Maximum plasma drug concentration.	Pre-dose Cycle 1 day 1/day 8, post dose Cycle 1 day 8/Cycle 3 day 1 2, 6, 24, 48, 72, 120 hours; pre-dose cycle 1 day 15, 22,cycle 2 day 1, cycle 4 day 1, cycle 6 day 1, cycle 12 day 1 and EOT
Immunogenicity incidence rate and its changes over time

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subjects voluntarily joined this study, signed the informed consent form, and exhibited good compliance;
Aged 18 to 80 years old, with an Eastern Cooperative Oncology Group (ECOG) score of 0 to 2, and an expected survival of more than 12 weeks;
Systemic light chain amyloidosis with diagnostic records (i.e., primary light chain amyloidosis);
Presence of measurable lesions;
At least one organ involved;
Have previously received at least one line of systemic treatment, and recurred and progressed after the remission of the last line treatment;
N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≤ 8500 ng/L;
The corresponding organ function conforms to the protocol requirements;
Women of childbearing age should agree to use contraception during the study period and for 6 months after its completion; they must have a negative serum pregnancy test within 7 days before enrollment in the study and must be non-lactating subjects; men should agree to use contraception during the study period and for 6 months after its completion.

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.