A Dose-escalation and Safety Study of CID-103 Followed by a Randomized, Open-label, Parallel-arm Multi-dose Study Evaluating the Efficacy and Tolerability of CID-103 in Adults With Chronic Immune Thrombocytopenia
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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 Investigation and Management of Primary Immune Thrombocytopenia (as locally applicable).
• 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.
Locations
Other Locations
China
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
The Second Affiliated Hospital of Kunming Medical University
NOT_YET_RECRUITING
Kunming
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Aaron Yang
aarony@casi.cn
+86 01 65618789
Time Frame
Start Date:2025-01-03
Estimated Completion Date:2026-12-30
Participants
Target number of participants:75
Treatments
Experimental: Part B (Randomized Dose Exploration) high-dose cohort
Each participant will receive selected high-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment.
Experimental: Part B (Randomized Dose Exploration) intermediate-dose cohort
Each participant will receive selected intermediate-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment.
Experimental: Part B (Randomized Dose Exploration) low-dose cohort
Each participant will receive selected low-dose. Once approximately 8 evaluable subjects per arm have completed approximately six weeks of treatment, an initial review of safety and efficacy will be conducted by the SMC to determine if there is one or more sub-optimal dose(s) that should be closed to further recruitment or if dose / regimens require adjustment.
Experimental: Part A (Dose Escalation) Cohort 1- 30 mg/30 mg
This is the initial dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design.
Experimental: Part A (Dose Escalation) Cohort 1- 30 mg/150 mg
This is the second dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design.
Experimental: Part A (Dose Escalation) Cohort 1- 150 mg/300 mg
This is the third dose cohort with accelerated dose escalation design. If a Grade ≥ 2 AE is reported in the cohort, the cohort will expand to three subjects and the study will then convert to a standard 3+3 design.
Experimental: Part A (Dose Escalation) Cohort 1- 150 mg/600 mg
This is the fourth dose cohort with standard 3+3 design.
Experimental: Part A (Dose Escalation) Cohort 1- 150 mg/900 mg
This is the fifth dose cohort with standard 3+3 design.