A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies (ARDENT)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Evaluate safety and tolerability of SC291
研究概览
简要总结
SC291-101 is a Phase 1 study to evaluate SC291 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 SC291 administered intravenously (IV) following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with NHL or CLL who have received two or more prior systemic treatments per standard of care (or after autologous stem cell transplant [ASCT] for NHL). This study will be conducted in 2 parts. Phase 1a: dose finding using a 3+3 design in subjects with NHL or CLL. Phase 1b: dose expansion to further evaluate safety and efficacy at the RP2D in subjects with LBCL and CLL.
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 subjects aged 18-80 years at the time of signing informed consent.
- •Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
- •Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
- •Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
- •Marginal zone lymphoma (dose escalation only)
- •Mantle cell lymphoma (dose escalation only)
- •CLL or SLL
- •Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant
- •ECOG performance status of 0 or
- •At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria
- •Life expectancy ≥12 weeks
排除标准
- •Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
- •History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
- •Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
- •Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
- •Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent).
- •History or presence of cardiac or CNS disorders as defined in the protocol
研究组 & 干预措施
SC291 Plus Chemotherapy Regimen
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with SC291
干预措施: SC291 (Drug)
结局指标
主要结局
Evaluate safety and tolerability of SC291
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 SC291(24 months)
- Evaluate cellular kinetics and persistence of SC291(24 months)
- Evaluate host immunogenicity to SC291(24 months)