ArticleCancer immunology, immunotherapy : CII2026
Safety and feasibility of 5T4 antibody-coupled allogeneic NK cell therapy for solid tumors: a first-in-human phase 1 trial.
Article in Cancer immunology, immunotherapy : CII, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06001684 (A Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients With Unresectable Locally Advanced Or Metastatic Solid Tumors), which is not on this map. Not yet cited in PubMed.
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A Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients With Unresectable Locally Advanced Or Metastatic Solid Tumors
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7 authors.
Funding
Abstract
backgroundPatients with unresectable locally advanced or metastatic solid tumors have limited therapeutic options. Antibody-guided allogeneic natural killer (NK) cell therapy represents a novel immunotherapeutic strategy to enhance tumor targeting and cytotoxicity by coupling NK cells with tumor-specific antibodies targeting antigens such as 5T4.
objectiveTo evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of IBR854, a non-viral, non-genetically modified, 5T4 antibody-coupled allogeneic NK cell therapy, in patients with advanced solid tumors. PATIENTS AND
methodsThis open-label, first-in-human phase 1 dose-escalation study enrolled 19 patients with unresectable locally advanced or metastatic solid tumors across five dose cohorts (3.0 × 10
resultsNo dose-limiting toxicities were observed. The most common treatment-emergent adverse events were elevated interleukin levels (42.1%), infusion-related reactions (31.6%), and fever (21.1%). No anti-drug antibodies were detected. The disease control rate was 43.8%. Median progression-free survival was 43 days. Pharmacokinetic analysis based on transgene copy number showed a dose-dependent prolongation of T
conclusionsIBR854 demonstrated an acceptable safety and tolerability profile and achieved disease stabilization in a subset of heavily pretreated patients with advanced solid tumors. These findings support further clinical development of 5T4-targeted antibody-coupled allogeneic NK cell therapy. Trial registration This study was registered at ClinicalTrials.gov (registration number: NCT06001684).
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