An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 59
- 主要终点
- Duration of targeted NSAEs
研究概览
简要总结
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
详细描述
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment
- •Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT
- •Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion.
排除标准
- 未提供
研究组 & 干预措施
Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed
consent for the LTFS
干预措施: Caribou-sponsored investigational therapy (Biological)
结局指标
主要结局
Duration of targeted NSAEs
时间窗: 15 Years
Duration of targeted NSAEs
Incidence of targeted NSAEs
时间窗: 15 Years
Incidence of targeted NSAEs
Frequency of targeted NSAEs
时间窗: 15 Years
Frequency of targeted NSAEs
Outcome of targeted NSAEs
时间窗: 15 Years
Outcome of targeted NSAEs
Incidence of AESIs
时间窗: 15 Years
Incidence of AESIs
Frequency of AESIs
时间窗: 15 Years
Frequency of AESIs
Duration of AESIs
时间窗: 15 Years
Duration of AESIs
Outcome of AESIs
时间窗: 15 Years
Outcome of AESIs
Incidence of targeted SAEs
时间窗: 15 Years
Incidence of targeted SAEs
Frequency of targeted SAEs
时间窗: 15 Years
Frequency of targeted SAEs
Duration of targeted SAEs
时间窗: 15 Years
Duration of targeted SAEs
Outcome of targeted SAEs
时间窗: 15 Years
Outcome of targeted SAEs
Incidence of AEs related to IP leading to death
时间窗: 15 Years
Incidence of AEs related to IP leading to death
次要结局
- Overall survival(15 years)