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

Last updated: March 20, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

4

Condition

Leukemia

Bone Neoplasm

Lymphoproliferative Disorders

Treatment

Cilta-cel

Clinical Study ID

NCT05201781
CR109123
2023-505530-10-00
2020-005521-84
68284528MMY4002
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Total Participants: 295
Treatment Group(s): 1
Primary Treatment: Cilta-cel
Phase: 4
Study Start date:
March 09, 2022
Estimated Completion Date:
October 30, 2037

Study 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.

Connect with a study center

  • UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • UZ Gent

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing 1816670, 100191
    China

    Site Not Available

  • West China Hospital Si Chuan University

    Chengdu, 610041
    China

    Site Not Available

  • West China Hospital, Si Chuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • West China Hospital Si Chuan University

    Chengdu 1815286, 610041
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350000
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, 350000
    China

    Site Not Available

  • Sun Yat-sen University Cancer Hospital

    Guangzhou, 510060
    China

    Site Not Available

  • Sun Yat-sen University Cancer Hospital

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • First Hospital, Zhejiang University Medical College

    Hangzhou, 310003
    China

    Site Not Available

  • First Hospital, Zhejiang University Medical College

    Hangzhou 1808926, 310003
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, 210029
    China

    Site Not Available

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

    Nanjing, 210008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962, 210029
    China

    Active - Recruiting

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

    Nanjing 1799962, 210008
    China

    Site Not Available

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University

    Shanghai, 200025
    China

    Active - Recruiting

  • Shanghai Changzheng Hospital

    Shanghai, 200003
    China

    Site Not Available

  • Shanghai Fourth People s Hospital

    Shanghai, 200434
    China

    Site Not Available

  • Shanghai Fourth People's Hospital

    Shanghai, 200434
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai 1796236, 200025
    China

    Active - Recruiting

  • Shanghai Changzheng Hospital

    Shanghai 1796236, 200003
    China

    Site Not Available

  • Shanghai Fourth People s Hospital

    Shanghai 1796236, 200434
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an 1790630, 710004
    China

    Site Not Available

  • CHRU de Lille Hopital Claude Huriez

    Nord, 59037
    France

    Active - Recruiting

  • Hopital Saint Louis

    Paris, 75010
    France

    Active - Recruiting

  • Hopital Saint Louis

    Paris 2988507, 75010
    France

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 57261
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, 64239
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel-Aviv, 64239
    Israel

    Active - Recruiting

  • Nagoya City University Hospital

    Nagoya, 467 8602
    Japan

    Site Not Available

  • Nagoya City University Hospital

    Nagoya 1856057, 467 8602
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Shibuya, 150-8935
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935
    Japan

    Site Not Available

  • Japanese Red Cross Medical Center

    Shibuya City 11808021, 150-8935
    Japan

    Site Not Available

  • VU Medisch Centrum

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • VU Medisch Centrum

    Amsterdam 2759794, 1081 HV
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • University Medical Center Groningen

    Groningen 2755251, 9713 GZ
    Netherlands

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • Mayo Clinic Cancer Center-Scottsdale

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic Cancer Center-Scottsdale

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305-5623
    United States

    Active - Recruiting

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford 5398563, California 5332921 94305-5623
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • Kansas University Medical Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Westwood 4281639, Kansas 4273857 66205
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester 5043473, Minnesota 5037779 55902
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School Of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School Of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08903
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York, New York 10029
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx, New York 10467
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Mount Sinai Medical Center

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Froedtert Memorial

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Froedtert Memorial

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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