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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06014775 | Anti-CD38 Antibody Treating Evans Syndrome | PHASE2 | RECRUITING | 10 | — | — | Dec 1, 2023 | Aug 1, 2025 | Feb 21, 2025 | 1 | China |
Overall response rate defined as improvement in any cytopenias by at least one grade, without worsening any other cytopenias or stable disease at least once within 8 weeks after the first dose.
Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD38 antibody treatment
| Arm | Type | Description |
|---|---|---|
| Intervention（Anti-CD38 antibody） | EXPERIMENTAL | 10 enrolled subjects : once a week x 8 doses |
| Name | Type | Description |
|---|---|---|
| Anti-CD38 antibody Injection | DRUG | intravenous Anti-CD38 antibody administration This study adopts a prospective, single arm, open design method. Ten subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks. The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment. The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment. |
Inclusion Criteria: * Male or female aged ≥18 years. * Prior to enrollment, a clinical diagnosis of primary Evans syndrome was made. * Platelet count \< 30×10\^9/L or Hb \< 100g/L or symptomatic anemia within 48 hours before the first administration of study drug; * Failure to achieve response or r...