A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]
研究概览
简要总结
The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma 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
- •Documented diagnosis of relapsed/refractory multiple myeloma (MM)
- •Subjects must have measurable disease
- •Subjects must have received ≥3 prior MM lines of therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic, renal, liver, pulmonary, and cardiac functions
- •Life expectancy of at least 3 months without treatment
排除标准
- •Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
- •Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
- •Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
- •Any prior allogeneic hematopoietic stem cell transplantation
- •Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion
研究组 & 干预措施
ALLO-605, ALLO-647
干预措施: ALLO-605 (Genetic)
ALLO-605, ALLO-647
干预措施: ALLO-647 (Biological)
ALLO-605, ALLO-647
干预措施: Fludarabine (Drug)
ALLO-605, ALLO-647
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605]
时间窗: 30 days
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion
Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-605 that will determine MTD/MAD and select the recommended Phase 2 dose (RP2D) of ALLO-605.
时间窗: 28 days
Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion
Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR)
时间窗: 12 months of study follow-up
次要结局
未报告次要终点