Actively Recruiting
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Led by Incyte Corporation · Updated on 2026-05-08
56
Participants Needed
40
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
CONDITIONS
Official Title
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingly sign a written informed consent form
- Age 18 years or older
- Confirmed diagnosis of primary immune thrombocytopenia (ITP) or primary warm autoimmune hemolytic anemia (wAIHA)
- No history of splenectomy
- Documented transient response to at least one prior early treatment such as corticosteroids, IVIG, or rituximab
- Received at least one standard course of rituximab with the last dose at least 6 months before study treatment
- Persistent or chronic active primary ITP or active primary wAIHA requiring treatment at inclusion
- Platelet count less than 30 x 10^9/L within 15 days before treatment start (for ITP) or hemoglobin less than 10 g/dL with positive direct antiglobulin test and evidence of hemolysis (for wAIHA)
- ECOG performance status of 0 to 2
- Willingness to avoid pregnancy or fathering children
You will not qualify if you...
- Clinical signs of cold agglutinin disease
- Life-threatening bleeding or urgent need to raise platelet count or hemoglobin within 2 weeks before treatment
- Prior treatment with anti-CD19 therapies
- Severe allergic reactions to monoclonal antibodies or known allergy to tafasitamab components
- Recent significant dose changes in disease-related therapies within 2 weeks before treatment
- Low immunoglobulin levels with frequent or severe infections
- Pregnant or breastfeeding women
- History of malignancy except certain treated cancers with no active disease for over 2 years
- Congestive heart failure with reduced heart function
- Positive tests for active hepatitis C or chronic hepatitis B infection
- HIV positivity or history of active viral infections
- Active systemic infections including COVID-19
- Severe immunocompromised state
- Receipt of live vaccines within 4 weeks before first tafasitamab infusion
- Blood clotting or platelet function disorders
- Active medical conditions requiring anticoagulation
- Any condition that could interfere with participation or pose risk as judged by investigators
- Toxicities from prior therapies must be low grade or stable
- Chronic infectious diseases requiring systemic treatment
- Unwillingness to receive blood transfusions
- Use of prohibited medications
- Incomplete recovery from major surgery
- Additional exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale
Glendale, Arizona, United States, 85304
Actively Recruiting
2
Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
Not Yet Recruiting
4
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
5
Gnp Research
Cooper City, Florida, United States, 33024
Actively Recruiting
6
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
8
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031-4867
Not Yet Recruiting
9
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Not Yet Recruiting
10
Versiti Bloodcenter of Wisconsin Bcw Milwaukee
Milwaukee, Wisconsin, United States, 53233
Not Yet Recruiting
11
St Vincent'S Hospital Sydney
Darlinghurst, New South Wales, Australia, 02010
Actively Recruiting
12
Townsville University Hospital
Douglas, Queensland, Australia, 04814
Actively Recruiting
13
Princess Alexandra Hospital Australia
Woolloongabba, Queensland, Australia, 04102
Actively Recruiting
14
Box Hill Hospital
Box Hill, Victoria, Australia, 03128
Actively Recruiting
15
Monash Medical Centre Clayton
Clayton, Victoria, Australia, 03168
Actively Recruiting
16
The Alfred Hospital
Melbourne, Victoria, Australia, 03004
Actively Recruiting
17
Chu Angers - Hôpital Hôtel Dieu
Angers, France, 49933
Not Yet Recruiting
18
Chu Caen - Hôpital de La Côte de Nacre
Caen, France, 14000
Not Yet Recruiting
19
Hôpital Henri Mondor
Créteil, France, 94010
Actively Recruiting
20
Chu Dijon - Hopital Du Bocage
Dijon, France, 21079
Actively Recruiting
21
Chu Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
22
Hopital Purpan
Toulouse, France, 31059
Actively Recruiting
23
Chru de Nancy- Hopital de Brabois
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
24
Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna
Bologna, Italy, 40138
Actively Recruiting
25
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Montichiari)
Brescia, Italy, 25123
Actively Recruiting
26
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola, Italy, 47014
Actively Recruiting
27
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
28
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
29
Azienda Ospedaliera Universitaria Federico Ii
Naples, Italy, 80131
Not Yet Recruiting
30
Azienda Ospedale Universita Di Padova
Padova, Italy, 35128
Not Yet Recruiting
31
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, Italy, 00136
Actively Recruiting
32
Amsterdam Umc, Locatie Vumc
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
33
Radboudumc
Nijmegen, Netherlands, 6500 HB
Actively Recruiting
34
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
35
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
36
Ico Badalona - Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 08916
Not Yet Recruiting
37
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
38
Castle Hill Hospital
Cottingham, United Kingdom, HU16 5JQ
Actively Recruiting
39
Barts Hospital
London, United Kingdom, E1 2ES
Actively Recruiting
40
Plymouth Hospitals Nhs Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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