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Tests treatment safety and results for Immune Thrombocytopenia
Official title Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
ClinicalTrials.gov ID: NCT07104565
What this study is testing
What is INCA000585?
INCA000585 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- 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.
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility 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...
- 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)...
- 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...
- 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...
- 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 apply.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Los Angeles, California, United States
- Lone Tree, Colorado, United States
- New Haven, Connecticut, United States
- Cooper City, Florida, United States
- Boston, Massachusetts, United States
- The Bronx, New York, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Darlinghurst, New South Wales, Australia
- Douglas, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Box Hill, Victoria, Australia
- Clayton, Victoria, Australia
- Melbourne, Victoria, Australia
- Angers, France
- Caen, France
- Créteil, France
- Dijon, France
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Los Angeles, California, United States; Lone Tree, Colorado, United States; New Haven, Connecticut, United States; Cooper City, Florida, United States; Boston, Massachusetts, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.