Persistence Evaluation and Response Study for Immunotherapy Safety Tracking of Participants Who Receive an AvenCell CAR-T Cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 178
- 试验地点
- 5
- 主要终点
- To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy
研究概览
简要总结
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of patients who participated in an AvenCell-sponsored clinical trial and received treatment with AvenCell's UniCAR or RevCAR platforms.
详细描述
To assess the incidence and severity of delayed serious adverse events (SAEs) possibly related to AVC-CAR-T cell therapy and AEs of special interest (AESIs), including secondary malignancies, neurologic disorders, rheumatologic or other autoimmune disorders, newly diagnosed serious hematologic disorders, severe infections, as well as pregnancy and newborn health complications where observed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who received an AVC-CAR-T cell therapy within an AVC-sponsored clinical trial.
- •Participant signed written informed consent for the AVC-PERSIST study.
排除标准
- •Participant is unable to provide written informed consent.
- •Participant is unable to comply with study requirements in the eyes of the Investigator.
研究组 & 干预措施
Allo-RevCAR01- T Targeting Module R-TM123 (AVC-201-01)
All participants who previously received Allo-RevCAR01- T Targeting Module R-TM123 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: Allo-RevCAR01- T with Targeting Module R-TM123 (Biological)
UniCAR02-T With Targeting Module TMpPSMA (UC02-PSMA-01)
All participants who previously received UniCAR02-T With Targeting Module TMpPSMA in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: UniCAR02-T-pPSMA (Biological)
Allo-QuadCAR01-T (AVC-203-01)
All participants who previously received Allo-QuadCAR01-T in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: Allo-QuadCAR01-T (Biological)
UniCAR02-T With Targeting Module TM123 (UC02-123-01)
All participants who previously received UniCAR02-T With Targeting Module TM123 in the parent study will be enrolled in this cohort for long-term follow-up.
干预措施: UniCAR02-T (IMP) With Targeting Module TM123 (Biological)
结局指标
主要结局
To assess delayed adverse events including secondary malignancies which are suspected related to previous AVC-CAR-T cell therapy
时间窗: Up to 15 years
* Number of participants with serious adverse events (SAEs) * Number of participants with new malignancies or recurrence of pre-existing malignancy * Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder * Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder * Number of participants with new incidence of serious hematologic disorder * Number of participants with new incidence of and/or recurring severe infection(s) * Number of pregnancy complications and newborn health complications
次要结局
- Overall Survival (OS)(Up to 15 years)
- Progression-Free Survival (PFS)(Up to 15 years)
- Event-free survival (EFS)(Up to 15 years)
- Cause of death(Up to 15 years)
- RCR in peripheral blood(15 years post last treatment)
- Pre-existing GvHD(15 years post last treatment)