Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07017725 | 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 | PHASE1 | RECRUITING | 75 | — | — | Jan 3, 2025 | Dec 30, 2026 | Jun 12, 2025 | 6 | China |
* 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)
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.
| Arm | Type | Description |
|---|---|---|
| Part B (Randomized Dose Exploration) high-dose cohort | EXPERIMENTAL | 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. |
| Part B (Randomized Dose Exploration) intermediate-dose cohort | EXPERIMENTAL | 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. |
| Part B (Randomized Dose Exploration) low-dose cohort | EXPERIMENTAL | 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. |
| Part A (Dose Escalation) Cohort 1- 30 mg/30 mg | EXPERIMENTAL | 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. |
| Part A (Dose Escalation) Cohort 1- 30 mg/150 mg | EXPERIMENTAL | 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. |
| Part A (Dose Escalation) Cohort 1- 150 mg/300 mg | EXPERIMENTAL | 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. |
| Part A (Dose Escalation) Cohort 1- 150 mg/600 mg | EXPERIMENTAL | This is the fourth dose cohort with standard 3+3 design. |
| Part A (Dose Escalation) Cohort 1- 150 mg/900 mg | EXPERIMENTAL | This is the fifth dose cohort with standard 3+3 design. |
| Name | Type | Description |
|---|---|---|
| CID-103 | DRUG | 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. |
Inclusion Criteria: 1. Male or female individuals aged 18 to 65 years at time of signing of ICF. Disease-related. 2. 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 Inter...