Document is current

Article History

Accepted: 22 April 2025

First Online: 7 May 2025

Declarations

:

: MajesTEC-1 was funded by Johnson & Johnson.

: Y.G., J.N., N.A.Q.C., S.H., Y.S., C.P.R., D.V., K.C., M.S., W.W., and N.H.B. are current employees of Johnson and Johnson and may hold stock in Johnson and Johnson. L.W. and X.M. were employees of Johnson and Johnson at the time the work was performed and may hold stock in Johnson and Johnson.

: The studies were conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Council for Harmonisation. The study protocols, amendments, and relevant documents were approved by the local independent ethics committee or institutional review board at each study site.

: All patients provided written informed consent prior to treatment.

: Not applicable.

: The data sharing policy of Johnson and Johnson is available at . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at .

: Not applicable.

: Y.G., J.N., N.A.Q.C., S.H., Y.S., C.P.R., D.V., M.N.S., W.W., and N.H.B. designed the models and collected, analyzed, and interpreted the data. K.C. contributed to the clinical study design, managed the clinical study, provided clinical oversight, and analyzed and interpreted data. All authors critically reviewed and revised the manuscript and approved the final manuscript.