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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Primary outcome measure(s)

• 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.
• 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.
• 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.
• Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia — From year 1 up to year 5
  Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported.
• Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia — 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).
• Number of Participants with New Incidence of Grade >= 3 Infection — From year 1 up to year 5
  Number of participants with new incidence of Grade \>=3 infection will be reported.
• Number of Participants with Serious Infection — From year 6 up to year 15
  Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
• Number of Participants with Serious Adverse Events (SAEs) — 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.
• Number of Participants with Related Serious Adverse Events Assessed by the Investigator — 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.

Trial sites (50)

+ 10 more sites — see the full list on the official registry below.

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