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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cilta-cel 		Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended or a study has been terminated. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.
  • Drug: Cilta-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.
    Other names:
    • JNJ-68284528
    • LCAR-B38M CAR-T cells

Recruiting Locations

Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona 85054

City of Hope
Duarte, California 91010

University of California San Francisco
San Francisco, California 94143

Stanford University Medical Center
Stanford, California 94305-5623

Moffitt Cancer Center
Tampa, Florida 33612

Emory University
Atlanta, Georgia 30322

Northwestern University
Chicago, Illinois 60611

University of Chicago
Chicago, Illinois 60637

Indiana University
Indianapolis, Indiana 46202

Kansas University Medical Center
Westwood, Kansas 66205

Dana Farber Cancer Institute
Boston, Massachusetts 02115

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Massachusetts General Hospital
Boston, Massachusetts 02215

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201

Mayo Clinic Rochester
Rochester, Minnesota 55902

Washington University School Of Medicine
St Louis, Missouri 63110

Hackensack University Medical Center
Hackensack, New Jersey 07601

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903

Roswell Park Cancer Institute
Buffalo, New York 14263

Mount Sinai Medical Center
New York, New York 10029

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Montefiore Medical Center
The Bronx, New York 10467

Levine Cancer Institute
Charlotte, North Carolina 28204

University of Pennsylvania
Philadelphia, Pennsylvania 19104

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232

Sarah Cannon Research Institute
Nashville, Tennessee 37203

MD Anderson Cancer Center
Houston, Texas 77030

Froedtert Memorial
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Detailed 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 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.