NCT04296461Unknown1 期
Phase 1 Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Welgenaleucel (UWC19) in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
UWELL Biopharma2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年7月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Dose Limiting Toxicities (DLT)
研究概览
简要总结
This is an open-label, single-center Phase 1/2 study with a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2) in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a primary diagnosis of B cell non-Hodgkin lymphoma
- •Histologically confirmed: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal Large B Cell Lymphoma (PMBCL), Transformation Follicular Lymphoma (TFL), High grade B-cell Lymphoma (HGBCL), Mantle cell Lymphoma (MANT), Burkitt Lymphoma (BURK), Lymphoblastic Lymphoma
- •Chemotherapy-refractory disease, defined as one of more of the following No response to last line of therapy OR Refractory post-autologous stem cell transplant (ASCT)
- •Individuals must have received adequate prior therapy including at a minimum:
- •anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and an anthracycline containing chemotherapy regimen for individual with transformed FL must have chemorefractory disease after transformation to DLBCL.
- •No active infection of HIV, HTLV and Syphilis
- •Adequate renal function
- •Adequate hepatic function
- •Adequate cardiac function
- •Adequate venous access for apheresis, and no other contraindications for leukapheresis
- •Voluntary informed consent is given.
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •Received allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
- •Body weight less than 30 kg
- •Pregnant or lactating women.
- •Uncontrolled active infection.
- •History of hepatitis B or hepatitis C infection.
- •Previously treatment with any gene therapy products or cell therapy product in past 28 days.
- •HIV infection.
- •Lymphoma with central nervous system (CNS) involvement
- •Have autoimmune disorders
- •Have active infection or inflammatory disorders
- •Prescreening test results in expansion rate less than 5 folds
- •An allergy to gentamycin and/or streptomycin
结局指标
主要结局
Dose Limiting Toxicities (DLT)
时间窗: 30 days after infusion
The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level.
Maximum Tolerated Dose (MTD)
时间窗: 30 days after infusion
A standard 3+3 trial design will be used for Welgenaleucel (UWC19) dose escalation cohorts.The dosing of Welgenaleucel (UWC19) will be divided into 5 cohorts, the subjects will receive Welgenaleucel (UWC19) once on day 14-18 after apheresis.
次要结局
未报告次要终点
研究者
研究点 (2)
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