CTIS2022-501927-25-00进行中（未招募）1 期
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects with Relapsed/Refractory Large B Cell Lymphoma (LBCL). - ALLO-501A-201
Allogene Therapeutics Inc.0 个研究点目标入组 100 人开始时间: 2023年2月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017., At least 1 measurable lesion at time of enrollment, Relapsed or refractory disease after at least 2 lines of chemotherapy., Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1., Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening., Adequate hematological function., Adequate Renal Function., Adequate Liver Function.
排除标准
- •Active central nervous system (CNS) involvement by malignancy., Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy., Any other active malignancies that required systemic treatment within 3 years prior to enrollment., Radiation therapy within 2 weeks prior to ALLO-647., Prior irradiation to >25% of the bone marrow., Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening., Autologous HSCT within last 6 months (24 weeks) or allogeneic HSCT within last 6 months (24 weeks) prior to ALLO-647., Subjects with active systemic bacterial, fungal, or viral infection requiring systemic treatment (including positive blood cultures within 7 days before starting lymphodepletion).
研究者
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