A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

  • Interventional
  • Recruiting
  • NCT05201781
Eligibility Details Visit Clinicaltrials.gov

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 Group
18 Years and up

Accepting Healthy Volunteers?

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

At a Glance

National Government IDNCT05201781


Lead SponsorJanssen Research & Development, LLC

Lead PhysicianAndrzej Jakubowiak


18 Years and up