ArticleAllergy2022
Anti-KIT monoclonal antibody CDX-0159 induces profound and durable mast cell suppression in a healthy volunteer study.
Article in Allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.
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Who cites it
46 citing papers in PubMed, 71 citations in OpenAlex.
- Trial
- Selective elimination of mast cells via Siglec-6-targeted nanodelivery of drug payload.The Journal of allergy and clinical immunology · 2026Article
- Developments in Mast Cell Research.The Journal of allergy and clinical immunology · 2026Review
- IMGT-NC Engineered Variants of INN Therapeutic IG or Antibodies and Related IgSF Proteins (TR, FPIA and CPCA): Bridging Sequences, Structures and Functions for AI.Biomolecules · 2026Review
- Emerging and Newly Approved Therapies for Antihistamine-Refractory Chronic Spontaneous Urticaria: A Narrative Review.Diseases (Basel, Switzerland) · 2026Review
- CD117 epitope-shielded hematopoietic stem cell transplantation with toxin-free conditioning and in vivo selection ameliorates a β-thalassemia model.bioRxiv : the preprint server for biology · 2026Article
- Structure and function of therapeutic antibodies approved by the US FDA in 2025.Antibody therapeutics · 2026Review
- Emerging Therapies for Anaphylaxis.Immunology and allergy clinics of North America · 2026Review
- Investigational Approaches in Treatment of Nonadvanced Mastocytosis.Current allergy and asthma reports · 2026Review
- On the Kinetics of Human Skin Mast Cell Depletion and Repopulation Following KIT Inhibition.Allergy · 2026Article
- Advancements and challenges in the management of chronic inducible urticaria.Frontiers in immunology · 2026Review
- Advances in the Management of Mediator-Related Symptoms in Non-Advanced Systemic Mastocytosis.ImmunoTargets and therapy · 2026Review
- The Immune Architecture of Eosinophilic Esophagitis: Mechanisms, Therapeutic Targets, and Precision Management.ImmunoTargets and therapy · 2026Review
- The Therapeutic Pipeline for Eosinophilic Esophagitis: Current Landscape and Future Directions.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Article
- Dual Inhibition of Mast Cells and Thymic Stromal Lymphopoietin Using a Novel Bispecific Antibody, CDX-622.Allergy · 2025Article
- Beyond Antihistamines: How Biologic and Small-Molecule Therapies Are Transforming Chronic Spontaneous Urticaria Care in Adults.Clinical drug investigation · 2025Review
- Role of Mast Cells in Human Health and Disease: Controversies and Novel Therapies.International journal of molecular sciences · 2025Review
- An Overview of Chronic Spontaneous Urticaria: Diagnosis, Management, and Treatment.Allergy, asthma & immunology research · 2025Review
- The recent advances of mast cells in the pathogenesis of atopic dermatitis.Frontiers in allergy · 2025Review
Corrections and comments
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Authors and funding
17 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMast cells (MC) are powerful inflammatory immune sentinel cells that drive numerous allergic, inflammatory, and pruritic disorders when activated. MC-targeted therapies are approved in several disorders, yet many patients have limited benefit suggesting the need for approaches that more broadly inhibit MC activity. MCs require the KIT receptor and its ligand stem cell factor (SCF) for differentiation, maturation, and survival. Here we describe CDX-0159, an anti-KIT monoclonal antibody that potently suppresses MCs in human healthy volunteers.
methodsCDX-0159-mediated KIT inhibition was tested in vitro using KIT-expressing immortalized cells and primary human mast cells. CDX-0159 safety and pharmacokinetics were evaluated in a 13-week good laboratory practice (GLP)-compliant cynomolgus macaque study. A single ascending dose (0.3, 1, 3, and 9 mg/kg), double-blinded placebo-controlled phase 1a human healthy volunteer study (n = 32) was conducted to evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159.
resultsCDX-0159 inhibits SCF-dependent KIT activation in vitro. Fc modifications in CDX-0159 led to elimination of effector function and reduced serum clearance. In cynomolgus macaques, multiple high doses were safely administered without a significant impact on hematology, a potential concern for KIT inhibitors. A single dose of CDX-0159 in healthy human subjects was generally well tolerated and demonstrated long antibody exposure. Importantly, CDX-0159 led to dose-dependent, profound suppression of plasma tryptase, a MC-specific protease associated with tissue MC burden, indicative of systemic MC suppression or ablation.
conclusionCDX-0159 administration leads to systemic mast cell ablation and may represent a safe and novel approach to treat mast cell-driven disorders.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.