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CT-P44

Development stage: Phase 3
Lead developer: Celltrion
Modality: Monoclonal Antibodies → Antibody-Based Therapeutics
Administration: Subcutaneous

Overview

CT-P44 is a proposed biosimilar to Darzalex Faspro (daratumumab and hyaluronidase), developed by Celltrion as a subcutaneous monoclonal antibody targeting CD38 for the treatment of relapsed or refractory multiple myeloma. It exhibits CD38 inhibition along with antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) effects, mirroring the reference product's mechanism to induce tumor cell killing in lymphocyte differentiation antigen CD38-expressing malignancies. Currently in global Phase 3 trials sponsored by Celltrion, including a double-blind, randomized study comparing pharmacokinetics, efficacy, and safety versus Darzalex Faspro in combination with lenalidomide and dexamethasone across 486 patients.[1][2][3][11]

Other names: Daratumumab Biosimilar (Celltrion, Inc.)

Targets

CD38 (Cluster of Differentiation 38)

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