NCT07017725

A Dose-escalation Study Followed by a Dose Optimal Study to Evaluate the Safety and Efficacy of CID-103 in Adults With Chronic Immune Thrombocytopenia

A 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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: CASI Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	CID-103	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.

Timeline

• Start date: 2025-01-03
• Primary completion: 2026-06-01
• Completion: 2026-12-30
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study