2025-520560-18-00招募中3 期
A phase 2 immunoPET imaging study with ZED88082A/CED88004S in patients with large B-cell lymphoma before and after CD19-directed CAR T-cell therapy
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy. Heterogeneity of ZED88082A/CED88004S uptake evaluated by measuring standardized uptake value (SUV) on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection.
研究概览
简要总结
The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell tumor invasion, as measured by the intensity of ZED88082A/CED88004S-PET imaging positive lesions.
研究设计
- 研究类型
- Interventional
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
- 否
入选标准
- •Subjects with histologically confirmed LBCL and subtypes according to the WHO 2016 criteria
- •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year]
- •Who fulfill the eligibility criteria for anti-CD19 CAR T-cell therapy according the Immune Effector Cell Working Group Tumorboard
- •Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures
- •Measurable disease, as defined by Lugano criteria
- •Signed informed consent
- •Age ≥18 at the time of signing informed consent
- •Life expectancy ≥12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Ability to comply with the protocol
排除标准
- •Signs or symptoms of active infection within 2 weeks prior to ZED88082A/CED88004S injection, unless treated to resolution
- •Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g. blinatumomab)
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ZED88082A/CED88004S, or that may affect the interpretation of the results or render the patient at high risk from complications
- •Pregnant or lactating women
- •HIV-positive patients
结局指标
主要结局
To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy. Heterogeneity of ZED88082A/CED88004S uptake evaluated by measuring standardized uptake value (SUV) on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection.
To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy. Heterogeneity of ZED88082A/CED88004S uptake evaluated by measuring standardized uptake value (SUV) on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection.
次要结局
- Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy
- Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy
- To perform correlative expression analysis between SUV parameters of ZED88082A tracer in the tumor, CD8 expression in tumor biopsy, and SUV parametersin the tumor and whole-body and CAR T-cell persistence, peak level and CAR T-cell phenotype as measured in the peripheral blood.
- Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, and grade 1-5 adverse events to CAR T-cell therapy, including cytokine release syndrome and neurotoxicity.
- to correlate ZED88082A/CED88004S uptake in lymphoma to radiated to non-radiated areas infield and outfield of radiation therapy in patients receiving radiation therapy that require bridging to CAR T-cell infusion
研究者
Tom van Meerten
Scientific
Universitair Medisch Centrum Groningen
研究点 (1)
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