Condition: Chronic Immune Thrombocytopenia · Sponsor: CASI pharmaceuticals, Inc.
The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with chronic immune thrombocytopenia (ITP). The main questions the study aims to answer are: * To evaluate the safety and tolerability of CID-103 in subjects with ITP with different increasing doses of CID-103. * To further evaluate the safety and tolerability of CID-103 at two or three dose levels and to select an optimal dose and administration regimen for CID-103 for further study of clinical efficacy. The study will be done in two parts: Part A will test increasing doses of CID-103 to see how safe it is and how well people tolerate it. Researchers will also aim to find a safe dose range. Part B will compare up to three different doses of CID-103 to see how well the medicine works and gather more safety and efficacy information. The goal is to find the optimal dose to use in future studies. CID-103 is given through an intravenous (IV) infusion. During the study, participants may receive treatment for up to 6 months, followed by a post-treatment safety follow-up period to check for ongoing safety and effectiveness. This study is an important step toward developing a new treatment for people living with chronic ITP. If CID-103 is found to be safe and effective, it could offer a new option for patients who do not respond well to current therapies.
This description comes directly from the study's public registry record.
Aaron Yang · +86 01 65618789 · aarony@casi.cn
Always discuss trial participation with your own doctor first.
| North China University of Science and Technology Affiliated Hospital | Tangshan, Hebei, China | Recruiting |
| Henan Cancer Hospital | Zhengzhou, Henan, China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang, Jiangxi, China | Not Yet Recruiting |
| Qilu Hospital of Shandong University | Jinan, Shandong, China | Not Yet Recruiting |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin, Tianjin Municipality, China | Recruiting |
| The Second Affiliated Hospital of Kunming Medical University | Kunming, Yunnan, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07017725