Condition: Systemic Light Chain Amyloidosis · Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
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.
This description comes directly from the study's public registry record.
Jin Lu, Doctor · 13311491805 · jinllu@sina.com
Always discuss trial participation with your own doctor first.
| Peking University First Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Peking University People's Hospital | Beijing, Beijing Municipality, China | Recruiting |
| Southwest Hospital, Third Military Medical University (Army Medical University) | Chongqing, Chongqing Municipality, China | Not Yet Recruiting |
| Fujian Medical University Union Hospital | Fuzhou, Fujian, China | Not Yet Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Guangzhou First Municipal People's Hospital | Guangzhou, Guangdong, China | Not Yet Recruiting |
| Peking University ShenZhen Hospital | Shenzhen, Guangdong, China | Not Yet Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guiyang, Guizhou, China | Not Yet Recruiting |
| Affiliated Hospital of Hebei University | Baoding, Hebei, China | Not Yet Recruiting |
| The First Affiliated Hospital of Harbin Medical University | Harbin, Heilongjiang, China | Not Yet Recruiting |
| Anyang People's Hospital | Anyang, Henan, China | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou, Henan, China | Not Yet Recruiting |
+ 15 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07266116