Plain language summary of the CARTITUDE-1 study of ciltacabtagene autoleucel for the treatment of people with relapsed or refractory multiple myeloma
Abstract
What is this summary about?
This is a summary of a clinical study called CARTITUDE-1. This study tested the anti-cancer chimeric antigen receptor-T cell (CAR-T) therapy ciltacabtagene autoleucel, abbreviated as cilta-cel, in people with multiple myeloma, a cancer that affects a specific type of blood cell called plasma cells. The participants in this study had relapsed or refractory disease, which means that their cancer did not improve or returned after 3 or more previous anti-cancer treatments.
How was the study in this summary conducted?
Ninety-seven participants went through the treatment process, which included collecting participants' own T cells (a type of immune cell), genetically modifying those T cells to recognize a certain protein found on myeloma cancer cells, pretreating with chemotherapy to prepare the participant's immune system to accept the modified T cells (cilta-cel), and finally injecting cilta-cel.
What were the results of this study?
Ninety-eight percent of participants showed decreases in indicators of cancer after treatment with cilta-cel. Seventy percent of participants were still alive approximately 28 months after treatment, and 55% of participants were still living without their cancer getting worse. The most common side effects were low blood cell levels, infections, cytokine release syndrome (a potentially serious side effect caused by overactivation of the immune system), and side effects that involved the nervous system (called neurotoxicities). Some participants experienced late-onset symptoms of neurotoxicity like the signs and symptoms of parkinsonism, meaning that they affected people's movement. Improvements in recognition of factors that increase the risk of these late-onset neurotoxicities and strategies to help avoid them has reduced their occurrence, although long-term monitoring for side effects is still an important part of treatment.
What do the results of the study mean?
Overall, almost all participants treated with cilta-cel had long-term reductions in signs of myeloma, and the majority of participants were alive and had no detectable signs of cancer over 2 years after being injected with cilta-cel.
Clinical Trial Registration:NCT03548207 (1b/2 CARTITUDE-1 study)
NCT05201781 (Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel)
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Acknowledgments
The authors acknowledge the patients and investigators who participated in this study, in addition to the staff members who enrolled patients or who were involved in data collection and analysis. Writing and editorial support for this summary was provided under the direction of the authors by Katie Yoest, PhD, and Carolyn H. Farnsworth, ELS; and funded by Janssen Pharmaceuticals, Inc., and Legend Biotech USA, Inc.
Financial & competing interests disclosure
JGB has received research funding from AbbVie, Acetylon Pharmaceuticals, Amgen, Bluebird Bio, Bristol Myers Squibb, Celgene, Celularity, CRISPR Therapeutics, EMD Serono, Genentech/Roche, GlaxoSmithKline, Icnos Sciences, Incyte, Janssen, Lilly, Novartis, Poseida Therapeutics, Sanofi, Takeda, and Teva, and has consulted or served in an advisory role for Bluebird Bio, Bristol Myers Squibb, Celgene, CRISPR Therapeutics, Janssen, Kite, a Gilead Company, Legend Biotech, Secura Bio, and Takeda. ADC has received research funding from GlaxoSmithKline and Novartis; has consulted or served in an advisory role for AstraZeneca, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen Oncology, Oncopeptides, Takeda, Roche/Genentech, Seattle Genetics, and Voratis; has provided expert testimony for Janssen Oncology; received travel, accommodations, or expenses from Celgene, GlaxoSmithKline, Janssen Oncology, and Takeda; and holds patents related to CAR-T therapies and biomarkers of cytokine release syndrome. SJ has consulted for or served in an advisory role for Bristol Myers Squibb, Janssen, Karyopharm Therapeutics, Legend Biotech, Sanofi, and Takeda; and received travel, accommodations, or expenses from Bristol Myers Squibb and Janssen Biotech. DM is an employee of Janssen Oncology, owns stock or other interests in Roivant, and has consulted or served in an advisory role for Celgene, Foundation Medicine, GlaxoSmithKline, Janssen Oncology, Legend Biotech, and Takeda. TM has received research funding from AMGEN, Janssen Oncology, and Sanofi, and has consulted for or served in an advisory role for GlaxoSmithKline and Legend Biotech. LP is an employee of Legend Biotech and has stock or other ownership interests in the company. Authors' full disclosure information can be found in the original research article. Writing and editorial support for this summary was provided under the direction of the authors by Katie Yoest, PhD, and Carolyn H. Farnsworth, ELS; and funded by Janssen Pharmaceuticals, Inc., and Legend Biotech USA Inc.
Open access
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