Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Janssen Research & Development, LLC
Summary
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 wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugCilta-cel
Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.
Locations (50)
- Mayo Clinic Cancer Center-ScottsdalePhoenix, Arizona
- City of HopeDuarte, California
- University of California San FranciscoSan Francisco, California
- Stanford University Medical CenterStanford, California
- Moffitt Cancer CenterTampa, Florida
- Emory UniversityAtlanta, Georgia