Chronic immune thrombocytopenia (ITP)
Conditions
Interventions
30mg/30mg group:CID-103 will be administered as an IV infusion. The first dose of CID-103 will be a priming dose. Subjects will then receive weekly doses of CID-103 at their assigned dose till week 6
30mg/150mg group:CID-103 will be administered as an IV infusion. The first dose of CID-103 will be a priming dose. Subjects will then receive weekly doses of CID-103 at their assigned dose till week 6
30mg/300mg group:CID-103 will be administered as an IV infusion. The first dose of CID-103 will be a priming dose. Subjects will then receive weekly doses of CID-103 at their assigned dose till week 6
150mg/600mg group:CID-103 will be administered as an IV infusion. The first dose of CID-103 will be a priming dose. Subjects will then receive weekly doses of CID-103 at their assigned dose till week
150mg/900mg group:CID-103 will be administered as an IV
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Men or women aged between 18-65 years old (including the threshold) at the time of signing the ICF. 2. Diagnosed with ITP and lasting>=3 months (diagnosed according to the American Society of Hematology's 2019 "Guidelines for Immune Thrombocytopenia" or "Diagnosis and Management of Primary Immune Thrombocytopenia: International Consensus Report Update" or "Chinese Guidelines for Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (2020 Edition)"). 3. The following results support the diagnosis of ITP: Previous ITP treatment (excluding thrombopoietin receptor agonists [TPO-RA]) was effective, platelet count reached>=30 × 109/L, and baseline detection value doubled. 4. Have received at least two lines of systemic SOC treatment (i.e. corticosteroids and another medication). Note: Subjects who have received first-line treatment and are currently receiving second-line treatment are also eligible to participate in this study. Exception: Subjects who cannot tolerate SOC treatment or who are unable to receive SOC treatment; Approval from the medical monitor is required. 5. The average platelet count obtained from at least two tests conducted at least one week apart during the screening period is=1500/µ L Note: If the researcher believes that this low level is caused by basic ITP treatment (such as immunosuppressants),>=1000/µ L lymphocytes = 800/µ L Note: If the researcher believes that this low level is caused by basic ITP treatment (such as immunosuppressants or steroids),>=500/µ L hemoglobin>=8g/dL Kidney: Estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiological Collaboration Group (CKD-EPI calculation formula) (see Appendix A)>=30 mL/min/1.73 m2 Liver: Serum total bilirubin1.5 × ULN, direct bilirubin must be2 years). When screening for fertil
Exclusion criteria
Exclusion criteria: 1. Have previously received any anti-CD38 monoclonal antibody drugs, or have been treated with anti Bruton tyrosine kinase (BTK), neonatal Fc receptor (FcRn) antagonists, or complement inhibitors within the three months prior to receiving the study drug. 2. Treatment with intravenous immunoglobulin (IV), subcutaneous immunoglobulin, or anti-D immunoglobulin within the 4 weeks prior to screening. 3. IgG=Grade III congestive heart failure as defined by the New York Heart Association (NYHA) guidelines (see Appendix E); Refractory hypertension is defined as a systolic blood pressure>160 mmHg and/or diastolic blood pressure>100 mmHg that cannot be controlled by antihypertensive drugs. 17. There is any medical history or clinical evidence of any surgical or internal diseases that researchers believe may interfere with the research results or pose additional risks to the participants in the study, especially any existing diseases that may pose additional risks to the participants if they develop IRR, namely diseases involving rapid progression or uncontrollable important organ systems - vascular, heart, lung (clinically significant respiratory diseases), gastr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of CID-103: Occurrence of DLTs (Part A only) Frequency of TEAEs Related AEs Grade 3/4 AEs Serious adverse events (SAEs) Fatal AEs AEs leading to CID-103 discontinuation up to Week 12 Percentage of subjects with at least one treatment-related Grade = 3 TEAE, SAE or AE leading to CID-103 discontinuation up to Week 12 (Part B only);Platelet response:A platelet count = 50 x 10^9/L and = 20 x 10^9/L above baseline achieved on at least two consecutive measurements at least seven days apart.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Platelet count: defined as platelet count = 30 x 10^9/L and > 2-fold increase in platelet count from baseline and absence of bleeding requiring medical intervention / treatment, measured on at least two consecutive occasions at least seven days apart.;Complete platelet response:The secondary efficacy endpoint includes percentage of subjects with complete platelet response, defined as platelet count = 100 x 109/L and absence of bleeding requiring medical intervention / treatment, measured on at least two consecutive occasions at least seven days apart.; | — |
Countries
China
Contacts
Public ContactZhang Lei
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed