Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Part of paid clinical trials in Glendale, Arizona.
- Sponsor
- Incyte Corporation
- Study ID
- NCT07104565
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Immune Thrombocytopenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- INCA000585 — DRUGTafasitamab will be administered intravenously at protocol defined timepoints.
Study Details
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
Key Dates
- Start date
- Dec 29, 2025
- Status verified
- May 2026
- Primary completion
- Sep 23, 2027
- Completion
- Mar 9, 2028
Study Design
- Enrollment
- 56 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1 - primary immune thrombocytopenia (ITP)INCA000585 will be administered intravenously.
- Experimental: Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA)INCA000585 will be administered intravenously.
Primary Outcome Measure
Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 52 weeks ]
Central Contacts
- Incyte Corporation Call Center (US)1.855.463.3463
- Incyte Corporation Call Center (ex-US)+800 00027423
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale | Glendale | Arizona | 85304 | - |
| Usc Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | - |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | - |
| Gnp Research | Cooper City | Florida | 33024 | - |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | - |
| Montefiore Medical Center | The Bronx | New York | 10461 | - |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031-4867 | - |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | - |
| Versiti Bloodcenter of Wisconsin Bcw Milwaukee | Milwaukee | Wisconsin | 53233 | - |
Find similar trials in Glendale, AZ
By research site
Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale· Glendale, AZUsc Norris Comprehensive Cancer Center· Los Angeles, CARocky Mountain Cancer Centers· Lone Tree, COYale University School of Medicine· New Haven, CTGnp Research· Cooper City, FLBeth Israel Deaconess Medical Center· Boston, MA
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