A Phase 1 Study Evaluating SC262, a Hypoimmune, Allogeneic CD22-directed CAR T Cell Therapy, in Relapsed and/or Refractory Non-Hodgkin's Lymphoma (VIVID)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Evaluate safety and tolerability of SC262
研究概览
简要总结
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
详细描述
This is an open-label, single arm, Phase 1, first-in-human (FIH) study to evaluate the safety and tolerability of SC262 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with Non Hodgkin's Lymphoma (NHL) who have received no more than 1 prior CD19-directed Chimeric Antigen Receptor T-Cells (CAR T) cell therapy. This study will be conducted in 2 parts. Dose finding using a 3+3 design in subjects with NHL. Dose expansion to further evaluate safety and efficacy at the recommended phase 2 dose (RP2D) in subjects with Large B-Cell Lymphoma (LBCL).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female Subject aged 18-80 years at the time of signing the informed consent
- •Histologic diagnosis of NHL (based on World Health Organization 2016 criteria) including:
- •LBCL, including Diffuse Large B Cell Lymphoma (DLBCL) not otherwise specified (NOS) (including DLBCL arising from indolent lymphoma), Primary Mediastinal Large B-Cell Lymphoma (PMBCL), High-Grade B-Cell Lymphoma (HGBCL), and Follicular Lymphoma (FL) Grade 3B
- •Marginal Zone Lymphomas (MZL)
- •Mantle Cell Lymphoma (MCL)
- •Relapsed or refractory disease after no more than 1 prior CD19-directed CAR T cell therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •At least 1 measurable (PET-positive) lesion per Lugano classification
- •Life expectancy ≥12 Weeks
排除标准
- •Prior CD22-directed therapy including CD22-directed CAR T cell therapy or other CD22 -directed antibody or cell therapy (e.g., Natural Killer (NK) cell)
- •History of central nervous system (CNS) involvement of lymphoma within 1 year prior to enrollment.
- •Autologous hematopoietic stem cell transplantation (HSCT) within 3 months before treatment with Lymphodepleting (LD) chemotherapy (or allogeneic HSCT at any time)
- •Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >10 mg/day prednisone or equivalent)
- •History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement, within 12 months of enrollment.
研究组 & 干预措施
SC262 Plus Chemotherapy Regimen
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC262
干预措施: SC262 (Drug)
结局指标
主要结局
Evaluate safety and tolerability of SC262
时间窗: 24 months
Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities
次要结局
- Evaluate preliminary anti-tumor activity of SC262(24 months)
- Evaluate cellular kinetics and persistence of SC262(24 months)
- Evaluate host immunogenicity to SC262(24 months)