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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05201781
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE January 10, 2022
First Posted Date  ICMJE January 21, 2022
Last Update Posted Date December 2, 2022
Actual Study Start Date  ICMJE March 9, 2022
Estimated Primary Completion Date July 29, 2037   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2022)
  • Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [ Time Frame: Up to 15 years ]
    Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
  • Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder [ Time Frame: Up to 15 years ]
    Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
  • Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder [ Time Frame: Up to 15 years ]
    Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
  • Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [ Time Frame: Up to 15 years ]
    Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.
  • Number of Participants with New Incidence of Grade >= 3 Infection [ Time Frame: Up to 15 years ]
    Number of participants with new incidence of Grade >=3 infection will be reported.
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2022)
  • Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [ Time Frame: Up to 15 years ]
    Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
  • Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder [ Time Frame: Up to 15 years ]
    Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
  • Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder [ Time Frame: Up to 15 years ]
    Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
  • Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder [ Time Frame: Up to 15 years ]
    Number of participants with new incidence of Grade >=3 hematologic disorder will be reported.
  • Number of Participants with New Incidence of Grade >= 3 Infection [ Time Frame: Up to 15 years ]
    Number of participants with new incidence of Grade >=3 infection will be reported.
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2022)
  • Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [ Time Frame: Up to 15 years ]
    Number of participants with measurable RCL in peripheral blood will be reported.
  • Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells [ Time Frame: Up to 15 years ]
    Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.
  • Pattern of Lentiviral Vector Integration Sites [ Time Frame: 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.
  • Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments [ Time Frame: 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.
  • Overall Survival (OS) [ Time Frame: Up to 15 years ]
    OS is measured from the date of randomization to the date of the participant's death.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2022)
  • Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [ Time Frame: Up to 15 years ]
    Number of participants with measurable RCL in peripheral blood will be reported.
  • Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells [ Time Frame: Up to 15 years ]
    Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.
  • Pattern of Vector Integration Sites [ Time Frame: Up to 15 years ]
    Pattern of vector integration sites if >1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.
  • Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments [ Time Frame: Up to 15 years ]
    Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments (example, chemistry and complete blood count [CBC]) 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.
  • Overall Survival (OS) [ Time Frame: Up to 15 years ]
    OS is measured from the date of randomization to the date of the participant's death.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Official Title  ICMJE Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Cilta-cel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2022)
228
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 29, 2037
Estimated Primary Completion Date July 29, 2037   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com
Listed Location Countries  ICMJE Belgium,   China,   Israel,   Japan,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05201781
Other Study ID Numbers  ICMJE CR109123
2020-005521-84 ( EudraCT Number )
68284528MMY4002 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP