A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
研究概览
简要总结
The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
- •Relapse or refractory disease after at least 2 lines of chemotherapy
- •At least 1 measurable lesion at time of screening.
- •Eastern Cooperative Oncology Group Performance Status of 0 or
- •Adequate hematological, renal, liver, pulmonary, and cardiac functions.
排除标准
- •Current or history of central nervous system (CNS) lymphoma.
- •Clinically significant CNS dysfunction.
- •ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-
- •Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
- •Systemic anticancer therapy within 2 weeks prior to study entry.
- •On-going treatment with immunosuppressive agents.
- •Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
- •Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
- •Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
- •Patients unwilling to participate in an extended safety monitoring period
研究组 & 干预措施
ALLO-647, ALLO-501
干预措施: Fludarabine (Drug)
ALLO-647, ALLO-501
干预措施: Cyclophosphamide (Drug)
ALLO-647, ALLO-501
干预措施: ALLO-501 (Genetic)
ALLO-647, ALLO-501
干预措施: ALLO-647 (Biological)
结局指标
主要结局
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
时间窗: 28 days
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
时间窗: 33 days
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
次要结局
未报告次要终点