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
- 55
- 试验地点
- 9
- 主要终点
- Number of subjects with delayed adverse events associated with administration of Cilta-cel. The following adverse events will be collected: - New malignancies and recurrence of preexisting malignancy (all grades)
研究概览
简要总结
To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •All subjects who received cilta-cel in a Company-sponsored clinical study are candidates for Study MMY
- •The inclusion criteria for the study are described below:
- •Subjects who have received at least one dose of cilta-cel in a Company-sponsored clinical study.
- •Subjects who have provided informed consent for Study MMY4002.
排除标准
- •No exclusion criteria are applicable in this study.
结局指标
主要结局
Number of subjects with delayed adverse events associated with administration of Cilta-cel. The following adverse events will be collected: - New malignancies and recurrence of preexisting malignancy (all grades)
Number of subjects with delayed adverse events associated with administration of Cilta-cel. The following adverse events will be collected: - New malignancies and recurrence of preexisting malignancy (all grades)
- New incidence or exacerbation of a preexisting neurologic disorder (all grades)
- New incidence or exacerbation of a preexisting neurologic disorder (all grades)
- New incidence or exacerbation of a preexisting rheumatologic or other autoimmune disorder (all grades)
- New incidence or exacerbation of a preexisting rheumatologic or other autoimmune disorder (all grades)
- New incidence of Grade ≥3 hematologic disorder including hypogammaglobulinemia (Years 1-5).Serious hematologic disorder including hypogammaglobulinemia (Years 6-15).
- New incidence of Grade ≥3 hematologic disorder including hypogammaglobulinemia (Years 1-5).Serious hematologic disorder including hypogammaglobulinemia (Years 6-15).
- New incidence of Grade ≥3 infection (Years 1-5).Serious infection(Years 6-15).
- New incidence of Grade ≥3 infection (Years 1-5).Serious infection(Years 6-15).
- All SAEs (Years 1-5). Only related SAEs as assessed by the Investigator (Years 6-15).
- All SAEs (Years 1-5). Only related SAEs as assessed by the Investigator (Years 6-15).
次要结局
- - Number of subjects with measurable RCL in peripheral blood.
- - Number of subjects with CAR transgene level >lower limit of quantitation (LLOQ) in peripheral blood cells.
- - Assessment of the pattern of lentiviral vector integration sites if at least 1% of cells in the blood sample or new malignancy are positive for vector sequences.
- - Long term follow-up on CAR-T therapy efficacy if the subject does not have confirmed disease progression or does not initiate subsequent antimyeloma therapy at the entry of the study and at any time of during the study.
- - Overall Survival (OS)
研究者
CTIS point of Contact
Scientific
Janssen - Cilag International