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Tests treatment safety and results for Chronic Immune Thrombocytopenia
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
ClinicalTrials.gov ID: NCT07017725
What this study is testing
What is CID-103?
CID-103 is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for chronic immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female individuals aged 18 to 65 years at time of signing of ICF. Disease-related.
- Diagnosed with ITP that has persisted for ≥ 3 months, diagnosed in accordance with The American Society of Hematology 2019 Guidelines for Immune...
- Diagnosis of ITP supported by a prior response to an ITP treatment (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet...
- Has received at least two lines of SOC systemic treatment (i.e., corticosteroids and one other agent).
- Has a mean platelet count ≤ 35 x 10\^9/L on at least two measurements at least one week apart during screening.
You likely can't join if
- Prior treatment with any anti-CD38 agent, or has been treated with anti-Bruton's tyrosine kinase (BTK), neonatal Fc receptor (FcRn) antagonist or...
- Use of IV immunoglobulin, subcutaneous immunoglobulin or anti-D immunoglobulin treatment within four weeks of screening.
- Treatment with rituximab or splenectomy within the three months prior to first dose of CID-103.
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within three weeks before screening.
- Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of CID-103 or...
- Active hemolytic anemia.
See the full eligibility criteria
- Male or female individuals aged 18 to 65 years at time of signing of ICF. Disease-related.
- Diagnosed with ITP that has persisted for ≥ 3 months, diagnosed in accordance with The American Society of Hematology 2019 Guidelines for Immune Thrombocytopenia or the Updated International Consensus Report on the...
- Diagnosis of ITP supported by a prior response to an ITP treatment (other than a thrombopoietin receptor agonists [TPO-RA]) that achieved a platelet count of ≥ 30 x 10\^9/L and a doubling of baseline measurement.
- Has received at least two lines of SOC systemic treatment (i.e., corticosteroids and one other agent).
- Has a mean platelet count ≤ 35 x 10\^9/L on at least two measurements at least one week apart during screening.
- If receiving standard background treatment for ITP, treatment should be stable in dose and frequency for at least four weeks prior to first dose of CID-103.
- Adequate organ function.
- Contraception: Female participants must either be non-pregnant or not breastfeeding and must have a negative pregnancy test. Male and female participants must meet the contraceptive requirements.
- Prior treatment with any anti-CD38 agent, or has been treated with anti-Bruton's tyrosine kinase (BTK), neonatal Fc receptor (FcRn) antagonist or complement inhibitor within three months prior to first dose of CID-103.
- Use of IV immunoglobulin, subcutaneous immunoglobulin or anti-D immunoglobulin treatment within four weeks of screening.
- Treatment with rituximab or splenectomy within the three months prior to first dose of CID-103.
- Use of anticoagulants or any drug with antiplatelet effect (such as aspirin) within three weeks before screening.
- Receiving other concurrent investigational therapies or have received investigational therapies within four weeks of the first dose of CID-103 or five half-lives (if shorter).
- Active hemolytic anemia.
- Diagnosed with severe chronic obstructive pulmonary disease (COPD), Global Initiative for Chronic Obstructive Lung Disease (GOLD Stage 3 or 4) or asthma.
- Has been diagnosed with myelodysplastic syndrome or other active malignancy.
- Known / clinically significant amyloidosis.
- Has a history of any thrombotic or embolic event within six months before screening.
- A history or evidence of cardiovascular risk including left ventricular ejection fraction \< 50%, clinically significant uncontrolled ventricular arrhythmia, acute coronary syndrome history, coronary angioplasty or...
- Clinically significant medical history or ongoing chronic illness.
- Known active infection with hepatitis B (HBV) (surface antigen) or infection with hepatitis C (HCV) in absence of sustained virologic response.
- History of known or suspected immunosuppression.
- Known active infection with human immunodeficiency virus (HIV) and CD4+ T cell count \< 350/μL.
- Karnofsky Performance Status ≤ 70.
The study team makes the final eligibility decision.
Where it's taking place
- Tangshan, Hebei, China
- Zhengzhou, Henan, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tangshan, Hebei, China; Zhengzhou, Henan, China; Nanchang, Jiangxi, China; Jinan, Shandong, China; Tianjin, Tianjin Municipality, China; Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.