A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
- Interventional
- Recruiting
- NCT05201781
Contact Information
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.
Gender
All
Age Group
18 Years and up
Accepting 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
- 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