NCT07735546尚未招募1 期
A Phase 1, Open-label, Multicenter Study of UB-VV500 With Rapamycin in Relapsed or Refractory Multiple Myeloma
Umoja Biopharma0 个研究点目标入组 100 人开始时间: 2026年10月1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
- 尚未招募
- 发起方
- 入组人数
- 100
- 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-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV500. The study will enroll patients with relapsed/refractory multiple myeloma.
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 multiple myeloma (MM) following treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
- •Measurable disease following completion of most recent anticancer therapy
- •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
- •Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
- •Solitary plasmacytomas without evidence of systemic disease
- •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-VV500 + rapamycin
Experimental
A single dose of UB-VV500 will be administered followed by treatment with rapamycin.
干预措施: UB-VV500 (Genetic)
UB-VV500 + rapamycin
Experimental
A single dose of UB-VV500 will be administered followed by treatment with rapamycin.
干预措施: Rapamycin (sirolimus) (Drug)
UB-VV500
Experimental
A single dose of UB-VV500 will be administered.
干预措施: UB-VV500 (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-VV500 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-VV500 administration)
研究者
相似试验
尚未招募
1 期
Study of TYK-01054 Capsules in Patients With Advanced Solid TumorsNCT07282873TYK Medicines, Inc219
招募中
2 期
SKB500 Combinations in Patients With Small Cell Lung CancerSmall Cell Lung CancerNCT07296809Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.80
招募中
2 期
SKB500 Combinations in Patients With Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT07700667Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.120
招募中
2 期
Clinical trial testing an investigational drug RVU120 for myelofibrosis (myeloproliferative neoplasm, MPN)Myelofibrosis2024-511688-27-00Ryvu Therapeutics S.A.83
招募中
1 期
A Clinical Study of PA5 in Patients With Advanced Solid TumorsAdvanced Solid TumorsCancerNCT07702162Chongqing Peg-Bio Biopharm Co., Ltd.49