{"doi":"10.4049/jimmunol.2100066","title":"Phase I Trial Characterizing the Pharmacokinetic Profile of N-803, a Chimeric IL-15 Superagonist, in Healthy Volunteers","abstract":"Abstract The oncotherapeutic promise of IL-15, a potent immunostimulant, is limited by a short serum t1/2. The fusion protein N-803 is a chimeric IL-15 superagonist that has a >20-fold longer in vivo t1/2 versus IL-15. This phase 1 study characterized the pharmacokinetic (PK) profile and safety of N-803 after s.c. administration to healthy human volunteers. Volunteers received two doses of N-803, and after each dose, PK and safety were assessed for 9 d. The primary endpoint was the N-803 PK profile, the secondary endpoint was safety, and immune cell levels and immunogenicity were measures of interest. Serum N-803 concentrations peaked 4 h after administration and declined with a t1/2 of ∼20 h. N-803 did not cause treatment-emergent serious adverse events (AEs) or grade ≥3 AEs. Injection site reactions, chills, and pyrexia were the most common AEs. Administration of N-803 was well tolerated and accompanied by proliferation of NK cells and CD8+ T cells and sustained increases in the number of NK cells. Our results suggest that N-803 administration can potentiate antitumor immunity.","journal":"The Journal of Immunology","year":2022,"id":253237,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":22,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.951,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":899204,"name":"Cameron E. Williams","orcid":null,"position":1,"is_corresponding":false},{"id":898671,"name":"Caroline Mart","orcid":"0000-0002-7526-6909","position":2,"is_corresponding":false},{"id":899205,"name":"Jonathan Beall","orcid":null,"position":3,"is_corresponding":false},{"id":898672,"name":"Linda MacPherson","orcid":"0000-0002-7153-8102","position":4,"is_corresponding":false},{"id":898673,"name":"Joseph Azar","orcid":"0000-0001-9518-2908","position":5,"is_corresponding":false},{"id":773494,"name":"Marzena Swiderska‐Syn","orcid":"0000-0001-7364-0728","position":6,"is_corresponding":false},{"id":692535,"name":"Paolo Manca","orcid":"0000-0002-3813-6339","position":7,"is_corresponding":false},{"id":898674,"name":"Barry C. Gibney","orcid":"0000-0003-0594-7669","position":8,"is_corresponding":false},{"id":32458,"name":"Mark D. Robinson","orcid":"0000-0002-3048-5518","position":9,"is_corresponding":false},{"id":478706,"name":"Carsten Krieg","orcid":"0000-0002-5145-7591","position":10,"is_corresponding":false},{"id":317574,"name":"Elizabeth G. Hill","orcid":"0000-0003-0896-4106","position":11,"is_corresponding":false},{"id":899206,"name":"Sharif A. Taha","orcid":null,"position":12,"is_corresponding":false},{"id":440871,"name":"Amy D. Rock","orcid":null,"position":13,"is_corresponding":false},{"id":322336,"name":"John H Lee","orcid":"0000-0002-5674-7969","position":14,"is_corresponding":false},{"id":321139,"name":"Patrick Soon‐Shiong","orcid":"0000-0002-4682-8298","position":15,"is_corresponding":false},{"id":407710,"name":"John Wrangle","orcid":"0000-0001-8998-4509","position":16,"is_corresponding":false},{"id":314037,"name":"Mark P. Rubinstein","orcid":"0000-0003-4748-0286","position":0,"is_corresponding":true}],"reference_count":37,"raw_metadata":null,"created_at":"2026-07-19T00:24:55.325369Z","pmid":"35228263","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}