Assessment of the Efficacy and Safety of Injectable TQB2934 (Subcutaneous Injection) in Systemic Light Chain Amyloidosis Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
TQB2934 injection: 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Numbers of subjects with adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs) — Baseline to the end of the study, about 4 years
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) — Baseline to CR,about 1.5 years
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.
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Peking University People's Hospital | Beijing | Beijing Municipality | Recruiting |
| Southwest Hospital, Third Military Medical University (Army Medical University) | Chongqing | Chongqing Municipality | Not Yet Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Not Yet Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Not Yet Recruiting |
| Guangzhou First Municipal People's Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Peking University ShenZhen Hospital | Shenzhen | Guangdong | Not Yet Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | Not Yet Recruiting |
| Affiliated Hospital of Hebei University | Baoding | Hebei | Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| Anyang People's Hospital | Anyang | Henan | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Not Yet Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| The first hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| The second Affiliated hospital of dalian medical university | Dalian | Liaoning | Not Yet Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | Not Yet Recruiting |
| Qingdao municipal hosptial (group) | Qingdao | Shandong | Not Yet Recruiting |
| Renji Hospital Shanghai Jiaotong University School Of Medicine | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| Chinese Academy of Medical Sciences Hematology Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | Not Yet Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
More Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials in Japan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07266116 on ClinicalTrials.gov ↗ ← All trials in Japan