Phase I Study of N-Acetylcysteine to Optimize Metabolic Tumor Microenvironment in CD19 CAR T-cell Therapy in Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 7
- 主要终点
- Maximum tolerated dose of N-AC
研究概览
简要总结
The purpose of this study is to test the safety of N-AC when given in combination with Yescarta to people with lymphoma. This study will test different doses of N-AC to find the highest dose that causes few or mild side effects in participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients must be 18 years of age or older
- •Patients who will receive axicabtagene ciloleucel for treatment of lymphoma
- •Patients must have adequate end organ function to be eligible for this study as defined by the following criteria:
- •ECOG performance status 0-2
- •Hematologic function with ANC ≥ 1000, Hgb ≥ 8, Plt ≥ 50k unless there is disease related hematologic toxicity
- •Renal function with CrCr ≥ 40 ml/min or Cr ≤ 1.5 x ULN
- •Hepatic function with ALT/AST ≤ 2.5 x ULN, TBili ≤ 1.5 x ULN.
排除标准
- •Patients with known allergy to N-AC
研究组 & 干预措施
Participants with Lymphoma, Cohort 1
The first dose escalation cohort in the study will be treated at 25% of that target dose level
干预措施: N-Acetylcysteine (Drug)
Participants with Lymphoma, Cohort 2
The second cohort in the study will be treated at 50% of that target dose level
干预措施: N-Acetylcysteine (Drug)
Participants with Lymphoma, Cohort 3
The third cohort in the study will be treated at 100% of that target dose level only if no DLTs are seen at lower doses.
干预措施: N-Acetylcysteine (Drug)
结局指标
主要结局
Maximum tolerated dose of N-AC
时间窗: Up to 1 year
This is a phase 1 dose escalation and expansion study to determine the maximum tolerated dose and recommended phase 2 dose of NAC given in conjunction with axicabtagene ciloleucel.
次要结局
未报告次要终点