This study is a clinical trial aimed at the marketing of TQB2934 for injection. The project plans to enroll 70 subjects, including 13-21 subjects in Phase Ib, to evaluate the safety and preliminary efficacy, pharmacokinetic (PK) characteristics, immunogenicity, and pharmacodynamic (PD) of TQB2934 for injection in subjects with systemic light chain amyloidosis, and to determine the recommended Phase II dose (RP2D). The Phase II plan involves enrolling 49 subjects, aiming to demonstrate that in adult subjects with relapsed/refractory systemic light chain amyloidosis who have previously received treatment with daratumumab and bortezomib, TQB2934 for injection significantly improves the hematological complete response (CR) rate compared to historical controls. The primary endpoint is the optimal hematological CR rate.
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;
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;
Single group
TQB2934 injection
DrugTQB2934 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.
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).
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.
Peak concentration (Cmax)
Maximum plasma drug concentration.
Immunogenicity incidence rate and its changes over time
Immunogenicity incidence rate and its changes over time
Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934
Exploring the correlation between soluble BCMA in peripheral blood and the efficacy of TQB2934
The best hematologic complete remission rate evaluated by researchers
The percentage of subjects with complete remission, which is the best hematological response evaluated by researchers.
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