A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05201781
This study collects long-term safety data on cilta-cel, a CAR-T therapy targeting BCMA. It involves participants previously treated with cilta-cel, with no new treatment administered. The study spans up to 15 years, focusing on delayed adverse events. Eligibility requires prior cilta-cel treatment and informed consent. Participants are monitored annually for safety evaluations.
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Program Overview
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.
Description
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.
Eligibility Criteria
Inclusion Criteria
- Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
- Participants who have provided informed consent for this study
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