2025-521286-27-00RecruitingPhase 3
INCA000585-201 - A PHASE 2A, OPEN-LABEL, MULTI-CENTER STUDY OF TAFASITAMAB IN ADULT PARTICIPANTS WITH AUTOIMMUNE BLOOD CELL DISORDERS
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Incyte Corp.
- Enrollment
- 5
- Locations
- 7
- Primary Endpoint
- AEs, assessed by changes in vital signs, through clinical laboratory blood sample evaluations, ECGs, ECOG performance status, and treatment interruptions or discontinuations.
Study Overview
Brief Summary
To determine the safety and tolerability of tafasitamab in participants with primary ITP or primary wAIHA. To determine the efficacy of tafasitamab in participants with primary ITP. To determine the efficacy of tafasitamab in participants with primary wAIHA.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Follow up Period
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant has signed informed consent, is ≥18 years old, and weighs ≥50 kg.
- •Confirmed historical diagnosis of one of the following autoimmune blood disorders: a. Primary ITP: isolated thrombocytopenia (peripheral blood count < 100 × 10⁹/L) in the absence of other causes or disorders associated with isolated thrombocytopenia. Participants must have persistent (3- to 12-month duration) or chronic (> 12-month duration) ITP. b. Primary wAIHA: isolated anemia and DAT result positive for IgG, with or without C3d, not due to another cause.
- •No history of splenectomy.
- •Confirmed transient response to at least 1 prior early-line treatment (eg, corticosteroids, IVIG, rituximab): a. Primary ITP: Increase in platelet count to ≥ 30 × 10⁹/L with at least a 2-fold increase of baseline platelet count b. 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. a. 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. b. 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. ITP: Platelet count <30 × 10⁹/L within 15 days before Day
- •a. Primary ITP: platelet count < 30 × 10⁹/L within the 15 days before treatment is scheduled to begin (Day 1). b. 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 0–
- •Willingness to avoid pregnancy or fathering children based on the criteria below. a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children, including refraining from donating sperm, from screening through 90 days (a spermatogenesis cycle) after the last dose of tafasitamab. b. Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy and refrain from donating oocytes from screening through 90 days after the last dose of study tafasitamab. c. Women not of childbearing potential: Eligible.
Exclusion Criteria
- •Clinical manifestations typical for cold agglutinin disease (eg, cold-induced symptoms, including acrocyanosis; DAT positive for C3d and generally negative for Ig; and/or cold agglutinin titer > 64).
- •Congestive heart failure (left ventricular ejection fraction of < 50%, assessed by 2-dimensional echocardiography or a multigated acquisition scan).
- •Active infections: a. HCV RNA positive. b. Chronic HBV (HBsAg or HBV DNA positive). c. HIV positive.
- •Active systemic infection (including COVID-19).
- •Severely immunocompromised (per investigator).
- •Live-attenuated vaccine within 4 weeks before first tafasitamab dose.
- •Coagulation or platelet function disorders; need for anticoagulation (e.g., recent stent).
- •Any condition interfering with study participation or data interpretation.
- •Unresolved toxicities from prior therapies (must be ≤ Grade 1, or ≤ Grade 2 if chronic).
- •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
- •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
- •Receipt of medications or investigational drugs for primary ITP/wAIHA within the following interval before the first administration of study drug: a. < 2 weeks for immunosuppressant drugs other than corticosteroids b. < 4 weeks or 5 half-lives for any investigational agent
- •Changes in doses (> 10%) of permitted disease-related therapies (see Section 6.6.1), including oral corticosteroids, TPO-RA (primary ITP participants), ESA (primary wAIHA participants) within 2 weeks prior to Day
- •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.
- •Pregnant or breastfeeding women.
- •History of malignancy except for the following: a. Malignancy treated with curative intent with no evidence of active disease for more than 2 years before screening. b. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled nonmelanoma skin cancer. c. Adequately treated carcinoma in situ without current evidence of disease
Outcomes
Primary Outcomes
AEs, assessed by changes in vital signs, through clinical laboratory blood sample evaluations, ECGs, ECOG performance status, and treatment interruptions or discontinuations.
AEs, assessed by changes in vital signs, through clinical laboratory blood sample evaluations, ECGs, ECOG performance status, and treatment interruptions or discontinuations.
Stable platelet response, 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.
Stable platelet response, 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.
Stable hemoglobin response, 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.
Stable hemoglobin response, 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.
Secondary Outcomes
- CR at Week 24, defined as platelet count ≥ 100 × 10⁹/L at Week 24 in the absence of clinically significant bleeding or rescue therapy.
- CR at Week 48 (complete remission), defined as platelet count ≥ 100 × 10 9 /L at Week 48 in the absence of clinically significant bleeding or rescue therapy.
- PR at Week 24, defined as platelet count ≥ 30 × 10 9/L and at least a 2-fold increase of baseline platelet count at Week 24 in the absence of clinically significant bleeding or rescue therapy.
- Duration of stable platelet response, defined as time from start of stable platelet response to loss of platelet response (< 50 × 10⁹/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first.
- Duration of CR, defined as time from the start of CR to loss of CR (platelet count < 100 × 10⁹/L), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first.
- Duration of response, defined as time from the date of the first response (PR or CR) to the loss of response (platelet count < 30 × 10⁹/L or a less than a 2-fold increase of baseline platelet count), clinically significant bleeding, need for rescue therapy, or death, whichever occurs first.
- CR at Week 24, defined as hemoglobin ≥ 12 g/dL and normalization of hemolytic markers (unconjugated bilirubin, LDH, haptoglobin, and reticulocytes) at Week 24 in the absence of rescue therapy.
- CR at Week 48 (complete remission), defined as hemoglobin ≥ 12 g/dL and normalization of hemolytic markers (unconjugated bilirubin, LDH, haptoglobin, and reticulocytes) at Week 48 in the absence of rescue therapy.
- PR at Week 24, defined as hemoglobin ≥ 10 g/dL and a ≥ 2 g/dL increase from baseline at Week 24 in the absence of rescue therapy.
- Duration of stable hemoglobin response, defined as time from start of stable hemoglobin response to loss of stable hemoglobin response (< 10 g/dL or a < 2 g/dL increase from baseline), need for rescue therapy, or death, whichever occurs first.
- Duration of CR, defined as time from start of CR to loss of CR (hemoglobin < 12 g/dL or abnormal hemolytic markers [unconjugated bilirubin, LDH, haptoglobin, and reticulocytes]), need for rescue therapy, or death, whichever occurs first.
- Duration of response, defined as time from the date of the first response (PR or CR) to the loss of response (hemoglobin < 10 g/dL), need for rescue therapy, or death, whichever occurs first.
- Change from baseline in serum antidrug antibody levels.
Investigators
Clinical Trial Information
Scientific
Incyte Corp.
Study Sites (7)
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