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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07104565 | Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders | PHASE2 | RECRUITING | 56 | — | — | Dec 29, 2025 | Mar 9, 2028 | Jun 1, 2026 | 40 | United States, Australia +5 |
Defined as any adverse event, either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 90 days after the last dose of study drug.
Defined as platelet count ≥ 50 × 109/L in the absence of clinically significant bleeding or rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary ITP.
Defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline in the absence of rescue therapy at ≥ 2 consecutive assessments any time after Day 56 until Week 48 in participants with primary wAIHA.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - primary immune thrombocytopenia (ITP) | EXPERIMENTAL | INCA000585 will be administered intravenously. |
| Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA) | EXPERIMENTAL | INCA000585 will be administered intravenously. |
| Name | Type | Description |
|---|---|---|
| INCA000585 | DRUG | Tafasitamab will be administered intravenously at protocol defined timepoints. |
Inclusion Criteria: \- Ability to comprehend and willingness to sign a written ICF for the study. * Aged ≥ 18 years. * Confirmed historical diagnosis of one of the following autoimmune blood disorders: * Primary ITP. * Primary wAIHA. * No history of splenectomy. * Confirmed transient response...