A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
2026年8月13日 更新者：Umoja Biopharma
A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
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).
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
274
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Christine Dehner
- 邮箱：christine.dehner@umoja-biopharma.com
研究联系人备份
- 姓名：Luke Walker, MD
- 电话号码：206-227-5056
- 邮箱：luke.walker@umoja-biopharma.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：UB-VV400 + rapamycin
A single dose of UB-VV400 will be administered followed by treatment with rapamycin.
|
Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
其他名称：
UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Phase 1: Percentage of participants with common adverse events (AEs)
大体时间：Up to 2 years after UB-VV400 administration
|
Percentage of participants with commonly reported AEs overall and by severity
|
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Overall response rate (ORR)
大体时间：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)
|
Up to 2 years after UB-VV4001 administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Phase 1: Overall response rate (ORR)
大体时间：Up to 2 years after UB-VV400 administration
|
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
|
Up to 2 years after UB-VV400 administration
|
|
Phase 1 and Phase 2: Complete response rate (CRR)
大体时间：Up to 2 years after UB-VV400 administration
|
Percentage of participants with a best overall response (BOR) of complete response (CR)
|
Up to 2 years after UB-VV400 administration
|
|
Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400
大体时间：Up to 8 days after UB-VV400 administration
|
Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400
|
Up to 8 days after UB-VV400 administration
|
|
Phase 2: Percentage of participants with common AEs
大体时间：Up to 2 years after UB-VV111 administration
|
Percentage of participants with commonly reported AEs overall and by severity
|
Up to 2 years after UB-VV111 administration
|
|
Phase 2: Duration of response (DOR)
大体时间：Up to 2 years after UB-VV400 administration
|
Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier
|
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Progression-free survival (PFS)
大体时间：Up to 2 years after UB-VV400 administration
|
Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier.
|
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Overall survival (OS)
大体时间：Up to 2 years after UB-VV400 administration
|
Duration from first administration of UB-VV400 to death from any cause
|
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Quality of life (QOL)
大体时间：Up to 2 years after UB-VV400 administration
|
Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
|
Up to 2 years after UB-VV400 administration
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Luke Walker, MD、Umoja Biopharma
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2031年8月1日
研究完成 (估计的)
2031年8月1日
研究注册日期
首次提交
2026年7月24日
首先提交符合 QC 标准的
2026年7月24日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年8月17日
上次提交的符合 QC 标准的更新
2026年8月13日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.