A5031024904- Blood groups and transfusion
- Platelet Disorders and Treatments
- Chronic Lymphocytic Leukemia Research
- Erythrocyte Function and Pathophysiology
- Complement system in diseases
- Immunodeficiency and Autoimmune Disorders
- Monoclonal and Polyclonal Antibodies Research
- Autoimmune Bullous Skin Diseases
- Lymphoma Diagnosis and Treatment
- Hemoglobinopathies and Related Disorders
- Diabetes and associated disorders
- Blood disorders and treatments
- Renal Transplantation Outcomes and Treatments
- Adenosine and Purinergic Signaling
- Autoimmune and Inflammatory Disorders Research
- Acute Lymphoblastic Leukemia research
- Glycosylation and Glycoproteins Research
- Celiac Disease Research and Management
- Blood properties and coagulation
- Immune Cell Function and Interaction
- Venous Thromboembolism Diagnosis and Management
- Hepatitis B Virus Studies
- Parvovirus B19 Infection Studies
- Neonatal Health and Biochemistry
- Coagulation, Bradykinin, Polyphosphates, and Angioedema
Georgetown University
2016-2025
MedStar Georgetown University Hospital
2016-2025
Georgetown University Medical Center
2014-2024
Bendigo Health
2023
Vince Lombardi Cancer Clinic
2023
Georgetown Lombardi Comprehensive Cancer Center
2019
Tennessee Oncology
2004
Sarah Cannon
2004
University of Pennsylvania
1995-2002
Regional Cancer Center
2002
Cold agglutinin disease is a rare autoimmune hemolytic anemia characterized by hemolysis that caused activation of the classic complement pathway. Sutimlimab, humanized monoclonal antibody, selectively targets C1s protein, C1 complex serine protease responsible for activating this
Sutimlimab, a first-in-class humanized immunoglobulin G4 (IgG4) monoclonal antibody that selectively inhibits the classical complement pathway at C1s, rapidly halted hemolysis in single-arm CARDINAL study recently transfused patients with cold agglutinin disease (CAD). CADENZA was 26-week randomized, placebo-controlled phase 3 to assess safety and efficacy of sutimlimab CAD without recent (within 6 months prior enrollment) transfusion history. Forty-two screening hemoglobin ≤10 g/dL,...
PURPOSE: We evaluated the efficacy and toxicity of weekly paclitaxel in patients with previously treated advanced urothelial cancer. PATIENTS AND METHODS: Patients cancer who had received one prior systemic chemotherapy regimen for disease evidence progression were eligible enrollment. 80 mg/m2 by 1-hour intravenous infusion weekly. A cycle therapy consisted four treatments. RESULTS: The study enrolled 31 patients. Mean age was 66 years, 45% three or more involved metastatic sites. Only 26%...
PURPOSE: We evaluated the efficacy and toxicity of weekly paclitaxel in patients with previously treated advanced urothelial cancer. PATIENTS AND METHODS: Patients cancer who had received one prior systemic chemotherapy regimen for disease evidence progression were eligible enrollment. 80 mg/m 2 by 1-hour intravenous infusion weekly. A cycle therapy consisted four treatments. RESULTS: The study enrolled 31 patients. Mean age was 66 years, 45% three or more involved metastatic sites. Only 26%...
Cold agglutinin disease (CAD) is a rare autoimmune hemolytic anemia mediated by IgM autoantibodies that trigger hemolysis via classical complement pathway. Increased incidence of thrombotic events (TEs) has been reported in patients with other forms hemolysis. The TEs CAD unknown.
Chronic/refractory immune thrombocytopenia (ITP) is a rare and pathophysiologically heterogeneous disorder with variable responsiveness to available treatments. Sutimlimab, first-in-class humanized monoclonal anti-C1s IgG4 antibody, selectively inhibits the classical pathway. This phase 1 study (NCT03275454) assessed safety, efficacy, pharmacokinetics, pharmacodynamics of biweekly sutimlimab in patients chronic/refractory ITP an inadequate response ≥2 therapies (platelet count ≤ 30 × 109/L)....
Purpose To determine the response rate of trastuzumab as first-line therapy in patients with HER-2 overexpressing metastatic breast cancer. assess feasibility and toxicity weekly paclitaxel/carboplatin or without following initial treatment trastuzumab. Patients Methods Sixty-one received (8 mg/kg followed by 4 mg/kg/wk) for 8 weeks. Responding additional weeks (4 mg/kg/wk), then proceeded to receive (2 mg/kg) combination paclitaxel 70 mg/m 2 carboplatin (area under curve, 2) 6 rest. Stable...
Abstract Patients with relapsed warm antibody autoimmune hemolytic anemia (wAIHA) have limited treatment options. Fostamatinib is a potent, orally administered spleen tyrosine kinase inhibitor approved in the United States and Europe for of adults chronic immune thrombocytopenia (ITP). This phase 2 study evaluated response to fostamatinib, at 150 mg BID or without food wAIHA active hemolysis hemoglobin (Hgb) <10 g/dL who had failed least one prior treatment. Hemoglobin levels safety...
Abstract Although Bruton tyrosine kinase inhibitors (BTKis) are generally well tolerated and less toxic than chemotherapy alternatives used to treat lymphoid malignancies, BTKis like ibrutinib have the potential cause new or worsening hypertension (HTN). Little is known about optimal treatment of BTKi-associated HTN. Randomly selected patients with malignancies on a BTKi antihypertensive drug(s) at least 3 months follow-up data were sorted into 2 groups: those diagnosed HTN before initiation...
Not available.
Abstract Cold agglutinin disease (CAD) is a rare, autoimmune, classical complement pathway (CP)‐mediated hemolytic anemia. Sutimlimab selectively inhibits C1s of the C1 complex, preventing CP activation while leaving alternative and lectin pathways intact. In Part A (26 weeks) open‐label, single‐arm, Phase 3 CARDINAL study in patients with CAD recent history transfusion, sutimlimab demonstrated rapid effects on hemolysis Results B (2‐year extension) study, described herein, that sustains...
Efgartigimod is approved in multiple regions for the treatment of gMG, ITP, and CIDP, being evaluated IgG-mediated autoimmune diseases. Here, we report long-term safety profiles efgartigimod IV PH20 SC across different dosing regimens diseases where has received regulatory approval. was assessed administration routes Phase 2, placebo-controlled 3, OLE studies participants with CIDP. Analyses were performed on all who ≥ 1 dose or partial placebo. Data from efgartigimod-treated pooled per...
Intravascular hemolysis related to cold agglutinin syndrome results from the activation of classical complement pathway by red blood cell (RBC) surface I/i antigen bound autoantibodies. Despite built-in mechanisms that limit continued downstream activation, some patients may develop life-threatening intravascular due formation membrane attack complexes. We present a case severe was treated successfully using proximal inhibition with commercial C1 esterase inhibitor. The role in controlling...
Abstract Previous studies have demonstrated low rates of seroconversion to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger RNA (mRNA) vaccines in patients with chronic lymphocytic leukemia (CLL). In this national collaboration 11 cancer centers the United States, we aimed further characterize and understand vaccine-induced immune responses, including T-cell impact CLL therapeutics (#NCT04852822). Eligible were enrolled cohorts (1) at time initial vaccination (2)...
Cold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia with substantial burden on patient's quality life. CARDINAL was 2-part, open-label, single-arm, multicenter phase 3 study evaluating the C1s inhibitor, sutimlimab, for treatment CAD. Part A consisted pivotal phase, part B extension assessing long-term safety and durability response including patient-reported outcomes, which focus this report. Altogether, 22 patients continued from to B, majority female (68.2%) median...
Abstract Background Cold agglutinin disease (CAD) is a rare autoimmune hemolytic anemia mediated by immunoglobulin M autoantibodies that bind to the “I” antigen on erythrocytes. IgM binding results in either agglutination at ≤37°C, activation of classical complement pathway, or both. Patients with CAD can have transient agglutination‐mediated circulatory symptoms triggered exposure cold conditions. Separately, patients experience complement‐mediated such as anemia, hemolysis, and fatigue,...
Abstract Thrombosomes are trehalose‐stabilized, freeze‐dried group O platelets with a 3‐year shelf life. They can be stockpiled, rapidly reconstituted, and infused regardless of the recipient's blood type. thus represent potential alternative platelet transfusion strategy. The present study assessed safety early signals efficacy in bleeding thrombocytopenic patients. We performed an open‐label, phase 1 single doses allogeneic at three dose levels cohorts, each consisting eight patients who...