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

NCT ID: NCT05201781

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2037-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cilta-cel

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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JNJ-68284528 LCAR-B38M CAR-T cells

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Mayo Clinic Cancer Center-Scottsdale

Phoenix, Arizona, United States

Site Status RECRUITING

City of Hope

Duarte, California, United States

Site Status RECRUITING

University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Stanford University Medical Center

Stanford, California, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

Kansas University Medical Center

Westwood, Kansas, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Washington University School Of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status RECRUITING

Mount Sinai Medical Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Froedtert Memorial

Milwaukee, Wisconsin, United States

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

West China Hospital Si Chuan University

Chengdu, , China

Site Status RECRUITING

Fujian Medical University Union Hospital

Fuzhou, , China

Site Status RECRUITING

Sun Yat-sen University Cancer Hospital

Guangzhou, , China

Site Status RECRUITING

First Hospital, Zhejiang University Medical College

Hangzhou, , China

Site Status RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, , China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, , China

Site Status RECRUITING

Shanghai Changzheng Hospital

Shanghai, , China

Site Status RECRUITING

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Shanghai Fourth People s Hospital

Shanghai, , China

Site Status RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status RECRUITING

CHRU de Lille Hopital Claude Huriez

Nord, , France

Site Status RECRUITING

Hopital Saint Louis

Paris, , France

Site Status RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Nagoya City University Hospital

Nagoya, , Japan

Site Status ACTIVE_NOT_RECRUITING

Japanese Red Cross Medical Center

Shibuya City, , Japan

Site Status ACTIVE_NOT_RECRUITING

VU Medisch Centrum

Amsterdam, , Netherlands

Site Status RECRUITING

University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Clinica Univ. de Navarra

Pamplona, , Spain

Site Status RECRUITING

Hosp Clinico Univ de Salamanca

Salamanca, , Spain

Site Status RECRUITING

Countries

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United States Belgium China France Israel Japan Netherlands Spain

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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68284528MMY4002

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005521-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-505530-10-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR109123

Identifier Type: -

Identifier Source: org_study_id