Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Details

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.

Keywords

Multiple Myeloma Cilta-cel

Eligibility

For people ages 18 years and up

Inclusion Criteria:

  • Participants who have received at least one dose of cilta-cel in a Janssen-sponsored clinical study
  • Participants who have provided informed consent for this study

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • City of Hope not yet accepting patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT05201781
Phase
Phase 4 research study
Study Type
Interventional
Last Updated