NCT06528301招募中1 期
A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
Umoja Biopharma13 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2025年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 13
- 主要终点
- Percentage of participants with common adverse events (AEs)
研究概览
简要总结
This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV111. The study will enroll patients with relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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) or chronic lymphocytic leukemia (CLL)
- •Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
- •No serious concomitant diseases or active/uncontrolled infections
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
- •Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.
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 (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
- •History of or active human immunodeficiency virus (HIV)
- •Active hepatitis B or 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-VV111 + rapamycin
Experimental
A single dose of UB-VV111 will be administered followed by treatment with rapamycin.
干预措施: rapamycin (Drug)
UB-VV111
Experimental
A single dose of UB-VV111 will be administered.
干预措施: UB-VV111 (Genetic)
UB-VV111 + rapamycin
Experimental
A single dose of UB-VV111 will be administered followed by treatment with rapamycin.
干预措施: UB-VV111 (Genetic)
结局指标
主要结局
Percentage of participants with common adverse events (AEs)
时间窗: Up to 2 years after UB-VV111 administration
Percentage of participants with commonly reported AEs overall and by severity
次要结局
- Overall response rate (ORR)(Up to 2 years after UB-VV111 administration)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
1 期
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid LeukemiaAcute Myeloid Leukemia (AML)NCT03625505AbbVie61
已完成
1 期
A Phase I/II Trial of VB-111 and Paclitaxel for Recurrent Platinum-Resistant Müllerian CancerPlatinum Resistant Ovarian CancerNCT01711970Vascular Biogenics Ltd. operating as VBL Therapeutics38
招募中
1 期
Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory CLL, SLL, MDS, MDS/MPN, AML, CMML-2, MPN-BP, ALL, MF, NHL, RT, MM or T-PLL.Non Hodgkin LymphomaT-cell-prolymphocytic LeukemiaAcute Lymphocytic LeukemiaMyeodysplastic SyndromeMyelodysplastic/Myeloproliferative NeoplasmMultiple MyelomaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaChronic Myelomonocytic Leukemia-2Myelodysplastic Neoplasm in Blast PhaseMyelofibrosisRichter TransformationNCT04771572Newave Pharmaceutical Inc100
招募中
1 期
UBX-303061 in Subjects With Relapsed/Refractory B-Cell MalignanciesNCT06590961Ubix Therapeutics, Inc.94
进行中（未招募）
1 期
A Phase 1 Study of BB3008 in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT06143007Broadenbio Ltd., Co.42