Actively Recruiting
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
Led by CASI Pharmaceuticals, Inc. · Updated on 2025-06-12
75
Participants Needed
6
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female individuals aged 18 to 65 years at time of signing of informed consent form
- Diagnosed with ITP that has lasted 3 months or more, according to established guidelines
- Diagnosis supported by prior response to an ITP treatment (other than thrombopoietin receptor agonists) achieving platelet count of at least 30 x 10^9/L and doubling baseline count
- Received at least two lines of standard systemic treatment, including corticosteroids and another agent
- Mean platelet count 35 x 10^9/L or lower on two measurements at least one week apart during screening
- Stable dose and frequency of standard background ITP treatment for at least 4 weeks before first CID-103 dose
- Adequate organ function
- Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test; all participants must follow contraceptive requirements
You will not qualify if you...
- Prior treatment with any anti-CD38 agent or recent treatment with anti-Bruton's tyrosine kinase, neonatal Fc receptor antagonist, or complement inhibitor within 3 months before first CID-103 dose
- Use of IV or subcutaneous immunoglobulin or anti-D immunoglobulin treatment within 4 weeks of screening
- Rituximab treatment or splenectomy within 3 months before first CID-103 dose
- Use of anticoagulants or antiplatelet drugs (e.g., aspirin) within 3 weeks before screening
- Receiving other investigational therapies or received them within 4 weeks or 5 half-lives before first CID-103 dose
- Active hemolytic anemia
- Diagnosed severe COPD (GOLD Stage 3 or 4) or asthma
- Diagnosed with myelodysplastic syndrome or other active cancer
- Known or clinically significant amyloidosis
- History of thrombotic or embolic event within 6 months before screening
- History or evidence of cardiovascular risks including low ejection fraction, uncontrolled arrhythmia, recent acute coronary syndrome, recent coronary procedures, severe heart failure, or refractory hypertension
- Clinically significant medical history or ongoing chronic illness
- Active hepatitis B or hepatitis C infection without sustained virologic response
- History of immunosuppression
- Active HIV infection with CD4+ T cell count below 350/µL
- Karnofsky Performance Status 70 or below
AI-Screening
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Trial Site Locations
Total: 6 locations
1
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China, 063000
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
3
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
4
Qilu Hospital of Shandong University
Jinan, Shandong, China, 50000
Not Yet Recruiting
5
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
6
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650000
Not Yet Recruiting
Research Team
A
Aaron Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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