Long-term Study for People Previously Treated with Ciltacabtagene Autoleucel
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT05201781
This study aims to gather information on any long-term side effects experienced by people who have previously received the treatment ciltacabtagene autoleucel (cilta-cel). It will help researchers understand the long-term safety of this therapy.
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Program Overview
The study is designed to collect information on any delayed side effects that may occur after receiving ciltacabtagene autoleucel (cilta-cel), a type of CAR-T cell therapy. This therapy targets a specific protein found on certain blood cells and cancer cells. The study will not involve any new treatments but will focus on monitoring participants for any long-term side effects. Participants will be followed for up to 15 years after their last dose of cilta-cel, with check-ups at least once a year. The study will include safety evaluations such as reviewing any side effects, lab test results, and physical exams, including neurological exams.
Description
Ciltacabtagene autoleucel (cilta-cel) is a CAR-T cell therapy that targets a protein called BCMA, found on certain blood cells and cancer cells. This study will not provide any new treatment but will monitor participants who have previously received cilta-cel to see if there are any long-term side effects. The study will last up to 15 years after the last dose of cilta-cel, with participants being checked at least once a year. Safety checks will include looking at any side effects, lab test results, and physical exams, including checks on the nervous system.
Eligibility Criteria
Inclusion Criteria
- Have received at least one dose of cilta-cel in a previous clinical study sponsored by the company.
- Have agreed to participate in this study by providing informed consent.
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