Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 295
- Locations
- 80
- Primary Endpoint
- Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Exclusion Criteria
- Not provided
Arms & Interventions
Cilta-cel
Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, 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 or a study has been terminated. 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: Cilta-cel (Drug)
Outcomes
Primary Outcomes
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 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 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).
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.
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.
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.
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.
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
- Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood(Up to 15 years)
- 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)
- Pattern of Lentiviral Vector Integration Sites(Up to 15 years)
- Overall Survival (OS)(Up to 15 years)
- 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)