INCA000585: Tafasitamab will be administered intravenously at protocol defined timepoints.
Study summary
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab):
* Primary ITP: Increase in platelet count to ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count.
* Primary wAIHA: Increase in hemoglobin to ≥ 10 g/dL with an increase of at least 2 g/dL from baseline.
* Received ≥ 1 standard course of rituximab (375 mg/kg × 4 weekly doses or 2 doses of 1000 mg flat dose every 2 weeks) with last dose given at least 6 months prior to initiation of study treatment. Note: If rituximab was the only prior therapy, individuals with NR to rituximab will not be eligible.
* Primary ITP: a PR (platelet count ≥ 30 × 109/L with at least a 2-fold increase of baseline platelet count) within 6 months of the last administered dose followed by relapse OR a CR (platelet count \> 100 × 109/L) lasting \< 48 weeks OR NR (platelet count \< 30 × 109/L or less than 2-fold increase of baseline platelet count or bleeding) within 6 months of the last administered dose.
* Primary wAIHA: a PR with hemoglobin ≥ 10 g/dL and with an increase of at least 2 g/dL from baseline OR a CR (hemoglobin ≥ 12 g/dL and normalization of hemolytic markers) OR NR (hemoglobin \< 10 g/dL or \< 2 g/dL increase of baseline hemoglobin).
* Persistent or chronic active primary ITP or active primary wAIHA with indication for treatment at the time of inclusion.
* Primary ITP: platelet count \< 30 × 109/L within the 15 days before treatment is scheduled to begin (Day 1).
Note: Participants treated with a rescue therapy during screening in response to a documented platelet count \< 30 × 109/L are eligible, irrespective of platelet count within 15 days of Day 1.
• Primary wAIHA: hemoglobin \< 10 g/dL documented with DAT result positive for IgG, with or without C3d, and evidence of hemolysis based on low haptoglobin, elevated LDH, and/or indirect bilirubin.
* ECOG performance status of 0 to 2.
* Willingness to avoid pregnancy or fathering children.
* Further inclusion criteria apply.
Exclusion Criteria:
* Clinical manifestations typical for cold agglutinin disease.
* Life-threatening bleeding or urgent need to elevate the platelet count for primary ITP or hemodynamic instability or hemoglobin \< 6 g/dL with urgent need to elevate hemoglobin for primary wAIHA within 2 weeks prior to Day 1.
* Prior treatment with anti-CD19 therapy (eg, mAb, bispecific T-cell engager, or CAR T cell) for any indication.
* Previous severe allergic reaction to a mAb or known allergy to any component/excipient of tafasitamab.
* Changes in doses (\> 10%) of permitted disease-related therapies, including oral corticosteroids and TPO-RA (primary ITP participants) within 2 weeks prior to Day 1, or change in ESA (primary wAIHA participants) dose within 2 weeks prior to Day 1.
* Evidence of hypogammaglobulinemia during screening (IgA \< 70 mg/dL, IgG \< 700 mg/dL, and/or IgM \< 40 mg/dL) and frequent and/or severe infections.
* Women who are pregnant or breastfeeding.
* History of malignancy except for the following:
* Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening.
* Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer.
* Adequately treated carcinoma in situ without current evidence of disease.
* Congestive heart failure (left ventricular ejection fraction of \< 50%, assessed by 2 dimensional echocardiography or a multigated acquisition scan).
* Participants with:
* Known positive test result for HCV (with HCV antibody serology testing) and a positive test for HCV RNA.
Note: Participants with positive serology must have been tested for HCV RNA and are eligible only in the case of negative HCV RNA test result.
• Known positive test result for chronic HBV infection (defined by HBsAg positivity or positive HBV DNA test result).
Note: Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable, provided that they are willing to undergo monthly ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines.
Note: Participants who have protective titers of HBsAb (HBsAb positive, HBcAb negative, and HBsAg negative) after vaccination or prior HBV infection are eligible.
• Seropositivity for or history of active viral infection with HIV.
* Active systemic infection (including infection with SARS-CoV-2).
* Participants in a severely immunocompromised state, per investigator's clinical assessment.
* Receipt of a live-attenuated vaccine within 4 weeks prior to the first infusion of tafasitamab (inactivated and killed vaccines are acceptable).
* Coagulation or platelet function abnormality.
* An active medical condition with a strong indication for treatment with anticoagulation agents (eg, intracoronary stent within 12 months).
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Toxicities related to prior therapies must be CTCAE (v5.0) ≤ Grade 1 at the time of study treatment/enrollment (except for chronic toxicities \[≤ Grade 2\] not expected to resolve).
* Chronic infectious disease requiring systemic antibiotics or antifungal or antiviral medications.
* Unwillingness to undergo transfusion with blood components.
* Current use of prohibited medication as described in the protocol.
* Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
* Further exclusion criteria apply.
Primary outcome measure(s)
Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to 52 weeks 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.
Stable platelet response — After Day 56 up to Week 48 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.
Stable hemoglobin response — After Day 56 up to Week 48 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.
Trial sites (39)
Facility
City
Region
Status
Palo Verde Cancer Specialists Palo Verde Hematology Oncology, Ltd Glendale
Glendale
Arizona
Recruiting
Usc Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
Rocky Mountain Cancer Centers
Lone Tree
Colorado
Recruiting
Yale New Haven Hospital
New Haven
Connecticut
Recruiting
Gnp Research
Cooper City
Florida
Recruiting
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Recruiting
Montefiore Medical Center
The Bronx
New York
Recruiting
Inova Schar Cancer Institute
Fairfax
Virginia
Recruiting
Fred Hutchinson Cancer Center
Seattle
Washington
Not Yet Recruiting
St Vincent'S Hospital Sydney
Darlinghurst
New South Wales
Recruiting
Townsville University Hospital
Douglas
Queensland
Recruiting
Princess Alexandra Hospital Australia
Woolloongabba
Queensland
Recruiting
Box Hill Hospital
Box Hill
Victoria
Recruiting
Monash Medical Centre Clayton
Clayton
Victoria
Recruiting
The Alfred Hospital
Melbourne
Victoria
Recruiting
Chu Angers - Hôpital Hôtel Dieu
Angers
France
Recruiting
Chu Caen - Hôpital de La Côte de Nacre
Caen
France
Recruiting
Hôpital Henri Mondor
Créteil
France
Recruiting
Chu Dijon - Hopital Du Bocage
Dijon
France
Recruiting
Chu Bordeaux - Hôpital Haut-Lévêque
Pessac
France
Recruiting
Hopital Purpan
Toulouse
France
Recruiting
Chru de Nancy- Hopital de Brabois
Vandœuvre-lès-Nancy
France
Recruiting
Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna
Bologna
Italy
Recruiting
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Montichiari)
Brescia
Italy
Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori
Meldola
Italy
Recruiting
Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
Ico Badalona. Hospital Universitario Germans Trias I Pujol
Badalona
Spain
Recruiting
Hospital Universitario La Paz
Madrid
Spain
Recruiting
Castle Hill Hospital
Cottingham
United Kingdom
Recruiting
Barts Hospital
London
United Kingdom
Recruiting
Plymouth Hospitals Nhs Trust
Plymouth
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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