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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05201781
Collaborator
(none)
228
31
1
184.7
7.4
0

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
228 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Actual Study Start Date :
Mar 9, 2022
Anticipated Primary Completion Date :
Jul 29, 2037
Anticipated Study Completion Date :
Jul 29, 2037

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cilta-cel

Participants who had previously received treatment with cilta-cel in a Company-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.

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
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [Up to 15 years]

      Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.

    2. Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder [Up to 15 years]

      Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.

    3. Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder [Up to 15 years]

      Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.

    4. Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [Up to 15 years]

      Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.

    5. Number of Participants with New Incidence of Grade >= 3 Infection [Up to 15 years]

      Number of participants with new incidence of Grade >=3 infection will be reported.

    6. Number of Participants with Serious Adverse Events (SAEs) [Up to 15 years]

      A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.

    Secondary Outcome Measures

    1. Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [Up to 15 years]

      Number of participants with measurable RCL in peripheral blood will be reported.

    2. Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells [Up to 15 years]

      Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.

    3. Pattern of Lentiviral Vector Integration Sites [Up to 15 years]

      Pattern of lentiviral vector integration sites if at least 1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.

    4. Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments [Up to 15 years]

      Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments if the participant does not have confirmed disease progression or does not initiate subsequent anti-myeloma therapy at the entry of the study and at any time of during the study will be reported.

    5. Overall Survival (OS) [Up to 15 years]

      OS is measured from the date of randomization to the date of the participant's death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Cancer Center-Scottsdale Phoenix Arizona United States 85054
    2 City of Hope Duarte California United States 91010
    3 University of California, San Francisco San Francisco California United States 94143
    4 University of Chicago Chicago Illinois United States 60637
    5 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    6 Massachusetts General Hospital Boston Massachusetts United States 02215
    7 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    8 Mayo Clinic Rochester Rochester Minnesota United States 55902
    9 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    10 Roswell Park Cancer Institute Buffalo New York United States 14263
    11 Mount Sinai Medical Center New York New York United States 10029
    12 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    13 Levine Cancer Institute Charlotte North Carolina United States 28204
    14 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    15 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    16 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    17 Froedtert Memorial Milwaukee Wisconsin United States 53226
    18 UZ Gent Gent Belgium 9000
    19 UZ Leuven Leuven Belgium 3000
    20 Peking University Third Hospital Beijing China 100191
    21 Fujian Medical University Union Hospital Fuzhou China 350000
    22 First Hospital, Zhejiang University Medical College Hangzhou China 310003
    23 Jiangsu Province Hospital Nanjing China 210029
    24 Shanghai Changzheng Hospital Shanghai China 200003
    25 Ruijin Hospital, Shanghai Jiao Tong University Shanghai China 200025
    26 Sheba Medical Center Ramat Gan Israel 57261
    27 Tel-Aviv Sourasky Medical Center Tel-Aviv Israel 64239
    28 Nagoya City University Hospital Nagoya Japan 467-8602
    29 Japanese Red Cross Medical Center Shibuya Japan 150-8935
    30 Clinica Univ. de Navarra Pamplona Spain 31008
    31 Hosp. Clinico Univ. de Salamanca Salamanca Spain 37007

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT05201781
    Other Study ID Numbers:
    • CR109123
    • 2020-005521-84
    • 68284528MMY4002
    First Posted:
    Jan 21, 2022
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022