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Article History

Received: 26 September 2025

Accepted: 12 February 2026

First Online: 26 March 2026

Declarations

:

: MajesTEC-1 was funded by Johnson & Johnson.

: N.W.C.J.V.d.D. has received research support from Janssen Pharmaceuticals, Amgen, Celgene, Novartis, Cellectis, and Bristol Myers Squibb, all paid to institution; and serves on advisory boards for Janssen Pharmaceuticals, Amgen, Celgene, Bristol Myers Squibb, Sanofi, Takeda, Roche, Novartis, Bayer, Adaptive, Galapagos, Kite Pharma, Merck, Pfizer, AbbVie, and Servier. A.L.G. served in a consulting or advisory role for AbbVie, Amgen, Bristol Myers Squibb/Celgene, CDR-Life, Gracell, GSK, Janssen Oncology, Novartis, Regeneron, and Smart Immune; received travel, accommodations, or expenses from Janssen; has a patent in the field of CAR-T cell therapy; and received research funding from CRISPR Therapeutics, Janssen Oncology, Novartis, and Tmunity Therapeutics. J.V.M. was a consultant for Johnson & Johnson in 2024. N.A.Q.C., J.N., Y.G., J.Z., X.Q., Y.S., C.P.R., D.V., C.H., T.S., A.Z., K.C., R.K., M.N.S., W.W., and N.H.B. are current employees of Johnson & Johnson and may hold stock in Johnson & Johnson.

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

: Not applicable.

: N.A.Q.C., J.N., Y.G., J.Z., X.Q., Y.S., C.P.R., D.V., C.H., T.S., A.Z., K.C., R.K., M.N.S., W.W., and N.H.B. contributed to the development of the analysis plan, data analysis, and interpretation. J.N., J.Z., X.Q., Y.S., C.P.R., M.N.S., and W.W. contributed to the population pharmacokinetic and/or quantitative systems pharmacology model development. C.H., T.S., A.Z., K.C., and R.K. contributed to the clinical study design, managed the clinical study, and provided clinical oversight. N.W.C.J.V.d.D., A.L.G., and J.V.M. cared for patients, supported the clinical trial, and contributed to data collection. All authors contributed to writing, critically reviewing, and revising the manuscript. All authors approved the final manuscript.