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Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.
Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells \[CAR-T\]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Kansas University Medical Center
Westwood, Kansas, United States
Start Date
March 9, 2022
Primary Completion Date
July 29, 2037
Completion Date
October 30, 2037
Last Updated
March 17, 2026
295
ESTIMATED participants
Cilta-cel
DRUG
Lead Sponsor
Janssen Research & Development, LLC
NCT06179888
NCT06152575
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04973605