Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 295
- 试验地点
- 80
- 主要终点
- Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Cilta-cel (Drug)
结局指标
主要结局
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- 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)