Actively Recruiting
A Dose-escalation and Safety Study of CID-103 Followed by a Randomized, Open-label Multi-dose Study Evaluating Safety and Efficacy in Adults With Chronic Immune Thrombocytopenia
Led by CASI pharmaceuticals, Inc. · Updated on 2025-06-12
75
Participants Needed
6
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CID-103, a new anti-CD38 monoclonal antibody, in adults with chronic immune thrombocytopenia (ITP) to assess its safety and effectiveness. This global Phase 1/2 trial aims to find a safe dose range and the optimal dose for further studies, particularly for patients who have not responded well to current treatments. The study is sponsored by CASI Pharmaceuticals, Inc. and involves adults aged 18 to 65 with chronic ITP diagnosed according to established guidelines. The study has two parts: Part A uses an accelerated dose escalation design to test increasing doses of CID-103 delivered by intravenous infusion. If significant side effects occur, the study switches to a standard dose escalation design. Part B is a randomized, open-label phase comparing up to three selected doses (low, intermediate, and high) to evaluate safety, tolerability, and platelet response. Treatment is given weekly for 6 weeks, then every two weeks up to week 12, and monthly if extended, for up to six months total. Participants will undergo regular monitoring during the treatment and a post-treatment safety follow-up period. Researchers will assess safety, tolerability, platelet counts, and platelet response over 12 weeks and up to 10 months. Other evaluations include organ function and response to prior treatments. The study includes detailed safety reviews and dose adjustments based on participant reactions, aiming to identify a dose regimen suitable for future clinical trials.
CONDITIONS
Brief 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 aged 18 to 65 years
- Diagnosed with chronic ITP persisting for at least 3 months according to established guidelines
- Prior response to an ITP treatment (excluding thrombopoietin receptor agonists) with platelet count increase
- Received at least two lines of standard systemic treatment including corticosteroids
- Mean platelet count of 35 x 10^9/L or less on at least two tests one week apart during screening
- Stable dose and frequency of any standard ITP treatment for at least four weeks before first study dose
- Adequate organ function
- Female participants must not be pregnant or breastfeeding and must have negative pregnancy test; all must meet contraceptive requirements
You will not qualify if you...
- Prior treatment with anti-CD38 agents, anti-Bruton's tyrosine kinase, neonatal Fc receptor antagonists, or complement inhibitors within 3 months
- Use of immunoglobulin treatments or anti-D immunoglobulin within 4 weeks before screening
- Rituximab treatment or splenectomy within 3 months before first study dose
- Use of anticoagulants or antiplatelet drugs such as aspirin within 3 weeks before screening
- Concurrent investigational therapies within 4 weeks or five half-lives before first study dose
- Active hemolytic anemia
- Diagnosed severe COPD (GOLD Stage 3 or 4) or asthma
- Diagnosed myelodysplastic syndrome or other active cancers
- Known or clinically significant amyloidosis
- History of thrombotic or embolic events within 6 months before screening
- Cardiovascular risks including low ejection fraction, arrhythmia, recent coronary events, severe heart failure, or refractory hypertension
- Significant medical history or ongoing chronic illness
- Active hepatitis B or C infection without sustained response
- Known or suspected immunosuppression
- Active HIV infection with low CD4+ T cell count
- Karnofsky Performance Status of 70 or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits to assess eligibility and perform required tests
Duration - Up to 6 months
Participants receive CID-103 via IV infusion starting once weekly for 6 weeks, then every two weeks up to Week 12. If treatment continues after Week 12, dosing occurs monthly for up to six months total.
Weekly visits for the first 6 weeks, then biweekly visits up to Week 12, followed by monthly visits if treatment continues
Duration - Up to 4 months after treatment ends
Participants are monitored for safety and platelet response after completing treatment.
Approximately 3 to 4 follow-up visits
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
Frequently Asked Questions
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