The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.
Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study
Open accessAbstract
PURPOSE: Mosunetuzumab is a bispecific antibody targeting CD20 and CD3 that redirects T cells to engage and eliminate malignant B cells and is being developed for relapsed or refractory (R/R) B-cell non-Hodgkin lymphomas (B-NHLs). METHODS: This first-in-human trial (ClinicalTrials.gov identifier: NCT02500407 ) evaluated the safety and tolerability and efficacy of mosunetuzumab in patients with R/R B-NHL and established the recommended phase II dose. Data from dose escalation are presented. Single-agent mosunetuzumab was administered intravenously in 3-week cycles, at full dose in cycle 1 day 1 (group A) or with ascending (step-up) doses during cycle 1 on days 1, 8, and 15 (group B), for eight or 17 cycles on the basis of tumor response. RESULTS: Two hundred thirty patients were enrolled. Doses up to 2.8 mg and 60 mg were assessed in groups A and B, respectively; maximum tolerated dose was not exceeded. In group B (n = 197), common adverse events (≥ 20% of patients) were neutropenia (28.4%), cytokine release syndrome (27.4%), hypophosphatemia (23.4%), fatigue (22.8%), and diarrhea (21.8%). Cytokine release syndrome was mostly low-grade (grade ≥ 3: 1.0%) and mainly confined to cycle 1. Across the doses investigated (group B), best overall response rates were 34.9% and 66.2% in patients with aggressive and indolent B-NHL, respectively, and complete response rates were 19.4% and 48.5%. Among patients with a complete response, the median duration of response was 22.8 months (95% CI, 7.6 to not estimable) and 20.4 (95% CI, 16 to not estimable) in patients with aggressive and indolent B-NHL, respectively. CONCLUSION: Mosunetuzumab, administered with step-up dosing, has a manageable safety profile and induces durable complete responses in R/R B-NHL. The expansion stage of the study is ongoing at the dose level of 1/2/60/60/30 mg selected for further study.
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Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Schuster, S. J., Bishop, M. R., Tam, C. S., Waller, E. K., Borchmann, P., McGuirk, J. P., Jäger, U., Jaglowski, S., Andreadis, C., Westin, J. R., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1804980 · Cited by 4,112
Self-citationCurrent concepts in the diagnosis and management of cytokine release syndrome.
Lee, D. W., Gardner, R., Porter, D. L., Louis, C. U., Ahmed, N., Jensen, M., Grupp, S. A., & Mackall, C. L. (2014) · Blood · doi:10.1182/blood-2014-05-552729 · Cited by 2,806
Locke, F. L., Ghobadi, A., Jacobson, C. A., Miklos, D. B., Lekakis, L. J., Oluwole, O. O., Lin, Y., Braunschweig, I., Hill, B. T., Timmerman, J. M., et al. (2019) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30864-7 · Cited by 2,286
Self-citationKTE-X19 CAR T cell therapy in relapsed or refractory mantle-cell lymphoma
Wang, M., Munoz, J., Goy, A., Locke, F. L., Jacobson, C. A., Hill, B. T., Timmerman, J. M., Holmes, H., Jaglowski, S., Flinn, I. W., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1914347 · Cited by 1,862
Self-citationDose Escalation Methods in Phase I Cancer Clinical Trials
Le Tourneau, C., Lee, J. J., & Siu, L. L. (2009) · JNCI: Journal of the National Cancer Institute · doi:10.1093/jnci/djp079 · Cited by 867
Hutchings, M., Mous, R., Clausen, M. R., Johnson, P., Linton, K. M., Chamuleau, M. E. D., Lewis, D. J., Sureda Balari, A., Cunningham, D., Oliveri, R. S., et al. (2021) · The Lancet · doi:10.1016/s0140-6736(21)00889-8 · Cited by 337
Cited by
Thieblemont, C., Phillips, T., Ghesquieres, H., Cheah, C. Y., Clausen, M. R., Cunningham, D., Do, Y. R., Feldman, T., Gasiorowski, R., Jurczak, W., et al. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.22.01725 · Cited by 584
T-cell-engaging bispecific antibodies in cancer
van de Donk, N. W. C. J., & Zweegman, S. (2023) · The Lancet · doi:10.1016/s0140-6736(23)00521-4 · Cited by 267
Sehn, L. H., Bartlett, N. L., Matasar, M. J., Schuster, S. J., Assouline, S. E., Giri, P., Kuruvilla, J., Shadman, M., Cheah, C. Y., Dietrich, S., et al. (2025) · Blood · doi:10.1182/blood.2024025454 · Cited by 94
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Metadata
- Authors
- Budde, L. E., Assouline, S., Sehn, L. H., Schuster, S. J., Yoon, S.-S., Yoon, D. H., Matasar, M. J., Bosch, F., Kim, W. S., Nastoupil, L. J., Flinn, I. W., Shadman, M., Diefenbach, C., O'Hear, C., Huang, H., Kwan, A., Li, C.-C., Piccione, E. C., Wei, M. C., Yin, S., & Bartlett, N. L.
- Venue
- Journal of Clinical Oncology
- Published
- 2022-02-10
- Volume
- 40
- Issue
- 5
- Pages
- 481-491
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4200255107
- Cited by
- 302
- References
- 6
- FWCI
- 30.95
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- The paper
- Budde, L. E., Assouline, S., Sehn, L. H., Schuster, S. J., Yoon, S.-S., Yoon, D. H., Matasar, M. J., Bosch, F., Kim, W. S., Nastoupil, L. J., Flinn, I. W., Shadman, M., Diefenbach, C., O'Hear, C., Huang, H., Kwan, A., Li, C.-C., Piccione, E. C., Wei, M. C., . . . Bartlett, N. L. (2022). Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.21.00931
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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