NCT04752358终止2 期
A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Adaptimmune
- 入组人数
- 3
- 试验地点
- 33
- 主要终点
- Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)
研究概览
简要总结
This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and <75 years
- •Diagnosis of Esophageal cancer or Esophagogastric junction cancer.
- •Previously received treatment for advanced or metastatic disease.
- •Measurable disease according to RECIST v1.
- •HLA-A*02 positive
- •Tumor shows MAGE-A4 expression confirmed by central laboratory.
- •ECOG Performance Status of 0 or
- •Left ventricular ejection fraction (LVEF) ≥50%.
- •Note: other protocol defined Inclusion criteria may apply
- •Key exclusion criteria
- •Positive for any HLA-A*02 allele other than: one of the inclusion alleles
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
- •Active autoimmune or immune mediated disease
- •Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
- •Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
- •Uncontrolled intercurrent illness
- •Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
- •Pregnant or breastfeeding
- •Note: other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- 未提供
结局指标
主要结局
Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)
时间窗: From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).
Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC
次要结局
- Replication Competent Lentivirus(From T-cell infusion to end study (up to 7 months))
- Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)(From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months))
- Time to Response (TTR) by IRAC(From T-cell infusion until first documented confirmed CR or PR)
- Duration of Response (DoR) by IRAC(From initial date of first confirmed response (CR or PR) until PD or death)
- Best Overall Response (BOR) by IRAC(From T-cell infusion until disease progression)
- Progression Free Survival (PFS) by IRAC(From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first)
- Overall Response Rate (ORR) by Investigator Assessment(From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).)
- Time to Response (TTR) by Investigator Assessment(From T-cell infusion until first documented confirmed CR or PR)
- Duration of Response (DoR) by Investigator Assessment(From initial date of first confirmed response (CR or PR) until PD or death)
- Best Overall Response (BOR) by Investigator Assessment(From T-cell infusion until disease progression (Up to 5 months))
- Progression Free Survival (PFS) by Investigator Assessment(From T-cell infusion until first documented PD, as assessed by Investigator, or death due to any cause, whichever occurs first (up to 5 months))
- Overall Survival (OS)(From T-cell infusion to death due to any reason (up to 7 months))
- Insertional Oncogenesis (IO)(From 1 year post T-cell infusion)
- Peak Persistence(From T-cell infusion to end study (up to 7 months))
- Time to Peak Persistence(From T-cell infusion to end study (up to 7 months))
- Concordance of the MAGE A-4 Clinical Trial Assay and in Vitro Diagnostic (IVD) Kit.(Screening visit)
研究者
研究点 (33)
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