At a glance
ClinicalIndex Comparison Record- ✓Aged 18 to 65 years
- ✓ITP persisted for ≥3 months, diagnosed per ASH 2019 Guidelines or Updated International Consensus Report
- ✓Prior response to non-TPO-RA ITP treatment with platelet count ≥30×10⁹/L and doubling of baseline
- ✓Received ≥2 lines of standard care systemic treatment (corticosteroids and one other agent)
- ✕Prior anti-CD38 agent, or anti-BTK, FcRn antagonist, or complement inhibitor within 3 months
- ✕IV immunoglobulin, subcutaneous immunoglobulin, or anti-D immunoglobulin within 4 weeks of screening
- ✕Rituximab or splenectomy within 3 months prior to first dose
- ✕Anticoagulants or antiplatelet drugs (e.g., aspirin) within 3 weeks before screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT07017725Phase 2RecruitingMonitorUpdated 12mo ago · Completion was 1mo agoA Dose-escalation and Safety Study of CID-103 Followed by a Randomized, Open-label, Parallel-arm Multi-dose Study Evaluating the Efficacy and Tolerability of CID-103 in Adults With Chronic Immune Thrombocytopenia
In Brief
A Phase 2 clinical trial evaluating CID-103 for Chronic Immune Thrombocytopenia. Currently recruiting, targeting 75 participants across 6 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Strength:20 mg/mL. Route of administration: IV infusion. Treatment duration: QW for 6 weeks, then at the same dose Q2W up to Week 12. If treatment continues after Week 12, dosing will occur monthly for up to a maximum treatment duration of six months.