Long-term Study for People Previously Treated with Ciltacabtagene Autoleucel

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60

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.

Patient Parameters

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.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic Cancer Center-Scottsdale85054PhoenixArizona
City of Hope91010DuarteCalifornia
University of California San Francisco94143San FranciscoCalifornia
Stanford University Medical Center94305-5623StanfordCalifornia
Emory University30322AtlantaGeorgia
Northwestern University60611ChicagoIllinois
University of Chicago60637ChicagoIllinois
Indiana University46202IndianapolisIndiana
Kansas University Medical Center66205WestwoodKansas
Dana Farber Cancer Institute02115BostonMassachusetts

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