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NCT Number: NCT05201781

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Gent, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cilta-cel

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.

Other names: JNJ-68284528, LCAR-B38M CAR-T cells

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

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

    Time frame: From year 1 up to year 5

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

  5. Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia

    Time frame: From year 6 up to year 15

    Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).

  6. Number of Participants with New Incidence of Grade >= 3 Infection

    Time frame: From year 1 up to year 5

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

  7. Number of Participants with Serious Infection

    Time frame: From year 6 up to year 15

    Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.

  8. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: From year 1 up to year 5

    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.

  9. Number of Participants with Related Serious Adverse Events Assessed by the Investigator

    Time frame: From year 6 up to year 15

    Number of participants with related serious adverse events assessed by the investigator will be reported. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Important dates

Study start
2022
Primary completion
2037
Study completion
2042
First posted
Jan 21, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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