Phase IbII Study of Injectable TQB2934 to Treat Adults With Systemic Light Chain Amyloidosis Who Have Relapsed After Prior Treatment

What this Trial Is About

Researchers are evaluating TQB2934 for injection in adults with systemic light chain amyloidosis who have relapsed or refractory disease after treatment with daratumumab and bortezomib. This Phase IbII clinical trial aims to assess the safety, preliminary effectiveness, pharmacokinetics, immunogenicity, and pharmacodynamics of TQB2934, a bispecific antibody targeting BCMA and CD3, to determine the recommended Phase II dose and whether it improves the hematological complete response rate compared to historical data. Participants will receive TQB2934 injections at doses of 40 mg or 60 mg. During the first three treatment cycles, the drug is administered once weekly. From cycles four to six, dosing occurs once every two weeks. For patients without complete remission or with minimal residual disease positivity after six cycles, the medication is given once every eight weeks, with treatment lasting up to two years. The study includes both Phase Ib and Phase II components with a planned enrollment of about 70 subjects. Throughout the study, participants will undergo regular assessments for adverse events, laboratory tests, and hematological responses evaluated by an independent committee. The trial will monitor pharmacokinetic and immunogenicity markers at multiple time points and evaluate organ responses and survival outcomes over approximately two years. This comprehensive monitoring aims to gather safety data and measure the best hematological response and other clinical outcomes during the study period.

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