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

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.

NCT Number	NCT07266116
Lead Sponsor	Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Conditions	Systemic Light Chain Amyloidosis
Enrollment	70 participants
Start Date	2025-12-26
Primary Completion	2029-02 (estimated)
Study Completion	2029-11 (estimated)
Updated on ClinicalTrials.gov	2026-05-08