2023-506641-35-00已完成2 期
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 14
- 主要终点
- ORR (complete response [CR] + partial response [PR]) per the Lugano Classification per Independent Radiology Review Committee (IRRC) review
研究概览
简要总结
To evaluate the efficacy of KTE-X19, as measured by objective response rate (ORR), in subjects with r/r MCL
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.
- •At least 1 measurable lesion
- •Platelet count ≥ 75,000/uL
- •Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/min
- •Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA), and no clinically significant electrocardiogram (ECG) findings
- •Baseline oxygen saturation > 92% on room air
排除标准
- •Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing
- •History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
- •Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
ORR (complete response [CR] + partial response [PR]) per the Lugano Classification per Independent Radiology Review Committee (IRRC) review
ORR (complete response [CR] + partial response [PR]) per the Lugano Classification per Independent Radiology Review Committee (IRRC) review
次要结局
- DOR
- Best objective response (BOR)
- ORR as determined by study investigators
- Progression-free survival
- Overall survival
- Incidence of adverse events (AEs) and clinically significant changes in laboratory values
- Incidence of anti-CD19 CAR antibodies
- Levels of anti-CD19 CAR T cells in blood
- Levels of cytokines in serum
- Changes over time in the EQ-5D scale score and visual analogue scale score
- Changes over time in the EORTC-QLQ-C30 score (Cohort 3 only)
研究者
EU CT Support
Scientific
Kite Pharma Inc.
研究点 (14)
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