A Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQB2934 for Injection in Subjects With Systemic Light Chain Amyloidosis
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 75 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 have experienced disease recurrence or progression after the last line of treatment was ineffective or the duration of response to the last line of treatment was less than 12 months;
• 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.