Trial reportClinical and translational science2025
Ethnic Sensitivity Assessment of Mosunetuzumab Pharmacokinetics and Pharmacodynamics in Chinese Patients With Relapsed or Refractory Follicular Lymphoma.
Trial report in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02500407 (An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Who cites it
2 citing papers in PubMed.
- Diversity in Translation: Equal Is Greater Than.Clinical and translational science · 2026Article
- Real-world safety profile of mosunetuzumab: a pharmacovigilance study based on the food and drug administration adverse event reporting system.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Mosunetuzumab, a CD20 × CD3 T-cell-engaging bispecific antibody, redirects T cells to eliminate malignant B cells. The purpose of YO43555 was to assess the pharmacokinetics (PK), safety, tolerability, and efficacy of mosunetuzumab as a single agent in Chinese patients with relapsed/refractory follicular lymphoma (R/R FL). The impact of ethnicity/region on the PK disposition of mosunetuzumab was assessed by non-compartmental analysis (NCA) as well as a population PK (popPK) approach. A previously established popPK model for intravenous mosunetuzumab, built from the global Phase I/II study GO29781, was externally validated with the PK data from study YO43555. Results from the PK analysis showed that the global popPK model adequately captured the individual PK of the Chinese population. The model predicted mosunetuzumab exposure metrics in Chinese patients were similar to those observed in Asian patients in the GO29781 R/R FL subpopulation with the same dose regimen, while the exposure differences between Chinese and Non-Asians from the global population were < 20%. An overlay of the exposure levels for Chinese patients on the established E-R relationship in global patients indicated that the mosunetuzumab exposure of Chinese patients remained within the established bounds for clinical safety and efficacy. The cytokine biomarkers IL-6 and TNF-α showed similar time-course patterns of release as observed in globally enrolled patients. In summary, mosunetuzumab PK disposition did not show significant ethnic sensitivity that would impact patient outcomes. Therefore, dose adjustment of the globally approved mosunetuzumab regimen is not warranted for Chinese patients with R/R FL. Trial Registration: ClinicalTrials.gov identifier: NCT02500407.
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