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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGInstitute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGThe Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
NOT_YET_RECRUITINGSafety 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)
Time frame: 10 months
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.
Time frame: 12 weeks
Platelet count
The secondary efficacy endpoint is 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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