A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 274
- 主要终点
- Phase 1: Percentage of participants with common adverse events (AEs)
研究概览
简要总结
This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •18 years or older
- •Provides voluntary written informed consent
- •Relapsed or refractory large B-cell lymphoma (LBCL)
- •Measurable disease according to Lugano 2014 criteria
- •Confirmed CD22 expression
- •No serious concomitant diseases or active/uncontrolled infections
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
排除标准
- •Women who are pregnant or breastfeeding
- •Current isolated central nervous system (CNS) involvement
- •Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
- •History of or active human immunodeficiency virus (HIV)
- •Active or chronic hepatitis B, or active hepatitis C
- •Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
- •Ongoing CNS disease that would preclude neurologic assessment
- •Uncontrolled angina or other acute heart disease
- •Currently receiving treatment in another interventional clinical trial.
研究组 & 干预措施
UB-VV400 + rapamycin
A single dose of UB-VV400 will be administered followed by treatment with rapamycin.
干预措施: UB-VV400 (Genetic)
UB-VV400 + rapamycin
A single dose of UB-VV400 will be administered followed by treatment with rapamycin.
干预措施: Rapamycin (sirolimus) (Drug)
结局指标
主要结局
Phase 1: Percentage of participants with common adverse events (AEs)
时间窗: Up to 2 years after UB-VV400 administration
Percentage of participants with commonly reported AEs overall and by severity
Phase 2: Overall response rate (ORR)
时间窗: Up to 2 years after UB-VV4001 administration
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
次要结局
- Phase 1: Overall response rate (ORR)(Up to 2 years after UB-VV400 administration)
- Phase 1 and Phase 2: Complete response rate (CRR)(Up to 2 years after UB-VV400 administration)
- Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400(Up to 8 days after UB-VV400 administration)
- Phase 2: Percentage of participants with common AEs(Up to 2 years after UB-VV111 administration)
- Phase 2: Duration of response (DOR)(Up to 2 years after UB-VV400 administration)
- Phase 2: Progression-free survival (PFS)(Up to 2 years after UB-VV400 administration)
- Phase 2: Overall survival (OS)(Up to 2 years after UB-VV400 administration)
- Phase 2: Quality of life (QOL)(Up to 2 years after UB-VV400 administration)