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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05201781
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, China, Israel, Japan, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional 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.

Arms & Interventions

Arms

Experimental: Cilta-cel

Participants who had previously received treatment with cilta-cel in a Janssen-sponsored clinical study (example, NCT04923893, NCT04181827, 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. 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Cancer Center-Scottsdale, Phoenix, Arizona

Status

Not yet recruiting

Address

Mayo Clinic Cancer Center-Scottsdale

Phoenix, Arizona, 85054

City of Hope, Duarte, California

Status

Not yet recruiting

Address

City of Hope

Duarte, California, 91010

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

University of Chicago, Chicago, Illinois

Status

Not yet recruiting

Address

University of Chicago

Chicago, Illinois, 60637

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Status

Not yet recruiting

Address

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Massachusetts General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02215

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Not yet recruiting

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Mayo Clinic Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic Rochester

Rochester, Minnesota, 55902

Mount Sinai Medical Center, New York, New York

Status

Not yet recruiting

Address

Mount Sinai Medical Center

New York, New York, 10029

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Not yet recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Levine Cancer Institute, Charlotte, North Carolina

Status

Not yet recruiting

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Froedtert Memorial, Milwaukee, Wisconsin

Status

Not yet recruiting

Address

Froedtert Memorial

Milwaukee, Wisconsin, 53226

International Sites

UZ Gent, Gent, Belgium

Status

Not yet recruiting

Address

UZ Gent

Gent, , 9000

UZ Leuven, Leuven, Belgium

Status

Not yet recruiting

Address

UZ Leuven

Leuven, , 3000

West China Hospital, Si Chuan University, Chengdu, China

Status

Not yet recruiting

Address

West China Hospital, Si Chuan University

Chengdu, , 610041

Shanghai, China

Status

Not yet recruiting

Address

Ruijin Hospital, Shanghai Jiao Tong University

Shanghai, , 200025

Xi'an, China

Status

Not yet recruiting

Address

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , 710004

Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

Status

Not yet recruiting

Address

Tel-Aviv Sourasky Medical Center

Tel-Aviv, , 64239

Nagoya City University Hospital, Nagoya, Japan

Status

Not yet recruiting

Address

Nagoya City University Hospital

Nagoya, , 467-8602

Clinica Univ. de Navarra, Pamplona, Spain

Status

Not yet recruiting

Address

Clinica Univ. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Not yet recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007