As of 17 May, the Likelihood of Approval (LoA) for Shanghai Bioray Laboratory’s gene therapy BCMA-UCART for relapsed multiple myeloma (MM) dropped 12 points, according to GlobalData’s LoA data. This is the result of a delay in the study’s estimated primary completion date from November 2020 to March 2022, according to a 7 March update to ClinicalTrials.gov.
The Shanghai, China-based Bioray Laboratory’s 20-patient Phase I is a dose escalation study of intravenously infused BCMA-UCART, measuring objective response rate for up to 90 days as its primary endpoint, according to ClinicalTrials.gov. Secondary endpoints include safety and persistence of BCMA-UCART, and the study is currently recruiting at Shanghai Tongji Hospital.
While the LoA prior to this news was 25%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has lowered the LoA to 13%. B-cell maturation antigen (BCMA) is a multiple myeloma tumour antigen, and BCMA-UCART is an allogenic chimeric antigen receptor in T cells (CART) with potential antitumor efficacy in multiple myeloma.
William Newton is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.