NCT05096234终止1 期
Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Primary outcome measure
研究概览
简要总结
This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.
详细描述
Primary Objectives:
* Explore the relationship of change in [18F]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.
Exploratory Analyses:
- Explore the relationship of change in [18F]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) ≥ 3 months) using RECISTv1.1 criteria
- Correlate the change in [18F]F-AraG PET signal in tumor lesions following CAR T cell therapy with maximum grade of Cytokine Release Syndrome (CRS) and neurotoxicity experienced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Age ≥ 18 years old
- •Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:
- •DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR
- •primary mediastinal (thymic) large B cell lymphoma
- •transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included
- •Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all the following criteria:
- •At least one measureable lesion away from head & neck, liver, kidneys, GI tract and bladder
- •At least one biopsy-accessible lesion or lymph node.
- •Express willingness to undergo low risk FNA or core biopsy of subcutaneous accessible lesion or lymph node.
- •Scheduled to receive commercial or research CAR T cell therapy with axicabtagene ciloleucel (Yescarta ®) as part of anticancer therapy.
- •Adequate renal and hepatic function, defined as:
- •Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr < 1.6 mg/dL
- •Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 mg/dL, except in cases of Gilbert's syndrome
- •Able to give informed consent. Subjects unable to give informed consent will not be eligible for this study
排除标准
- •Women who are pregnant or breastfeeding.
- •Subjects with significant GI disease involvement by PET imaging
- •In the investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures.
研究组 & 干预措施
[18F]F-AraG PET
Experimental
Subjects will undergo PET imaging at the following time points:
- Baseline, prior to lymphodepleting chemotherapy: [18F]F-AraGPET/CT, followed the next day by FDG-PET/CT
- At peak CAR expansion: Day 4 (± 2 days) post-CAR infusion:
[18F]F-AraG PET
- At Day +28 (± 4 days) post-CAR infusion: FDG-PET/CT Subjects will have a paired biopsy after each imaging time point, if possible. Subjects will be followed for safety of [18F]F-AraG for 30 days after last dose
干预措施: [ 18F]F-AraG PET (Drug)
结局指标
主要结局
Primary outcome measure
时间窗: values obtained on Day 0 and Day 4 (± 2 days)
Spearman correlation between changes in SUV in \[18F\]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples
次要结局
未报告次要终点
研究者
研究点 (1)
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