肿瘤细胞治疗研究
英文原题：PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项 I 期注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 32 例。试验地点：美国 · 旧金山（共 1 个中心）。登记号：NCT06522932。
不限性别 · ≥ 18 Years · 接受健康志愿者
纳入标准 1. 符合以下疾病特征：组织学确诊为复发/难治性非霍奇金淋巴瘤（NHL），且至少接受过一线治疗；计划接受市售CD19靶向CAR-T 细胞产品治疗。 2. 愿意接受治疗后的肿瘤活检，且有可安全接近的软组织病灶。 3. 年龄≥18岁。 4. 能够理解并愿意签署书面知情同意书。 5. ECOG体能状态评分<2（Karnofsky评分>60%）。 6. 经治疗的脑转移患者可以入组，但中枢神经系统（CNS）靶向治疗后的脑部影像随访须显示疾病未进展。 7. 新发或进展性脑转移（活动性脑转移）或软脑膜病患者，如主治医生判断无需立即进行CNS特异性治疗，且治疗首周期内不太可能需要该治疗，也可入组。 8. 既往或当前患有其他恶性肿瘤者，如其自然病程或治疗不会干扰本研究方案安全性或疗效评估，也可入组。64Cu-GRIP B对发育中胎儿的影响尚不明确，因此有生育能力的受试者须同意采取充分避孕措施：所有受试者在参加研究期间及研究干预末次给药后1个月内均须使用屏障避孕法。若受试者或其伴侣在参加研究期间怀孕或怀疑怀孕，应立即告知主治医生。按本方案接受治疗或入组的男性受试者也须同意在研究前、研究期间及研究治疗末次给药后1个月内采取充分避孕措施。 排除标准 1. 主要研究者认为会影响受试者遵守研究程序的任何情况。 2. 妊娠者不得参加本研究，因为64Cu-GRIP B对发育中胎儿的影响尚不明确。哺乳期父母接受64Cu-GRIP B治疗可能对婴儿造成尚不明确但潜在的不良事件风险；若哺乳期父母接受该治疗，须停止哺乳。 3. 对64Cu-GRIP B或其任何辅料过敏。
Inclusion Criteria: 1. Disease characteristics, as defined by: 1. Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy. 2. Planned treatment with a commercially available CD19 targeting CAR-T cell product. 2. Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion. 3. Age \>= 18 years. 4. Ability to understand and the willingness to sign a written informed consent document. 5. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%). 6. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 7. Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. 8. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The effects of 64Cu-GRIP B on the developing human fetus are unknown. For this reason, participants of childbearing potential must agree to use adequate contraception: all participants should use barrier protection for the duration of study participation and for one month after last administration of study intervention. Should a participant become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Male participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and one month after last administration of study treatment. Exclusion Criteria: 1. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures. 2. Pregnant participants are excluded from this study because the effects of 64Cu-GRIP B on the developing human fetus are unknown. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with 64Cu-GRIP B, breastfeeding should be discontinued if the nursing parent receives 64Cu-GRIP B. 3. Hypersensitivity to 64Cu-GRIP B or any of its excipients.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Proportion of positive tumors at the post-CAR-T scan · The proportion of known lesions with detectable radiotracer uptake on conventional imaging will be reported along with 95% binomial exact confidence intervals. Tumors will be defined as positive if they are focally avid with maximum standardized uptake value (SUVmax) \>1.5 fold above adjacent background. · From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total
次要终点：Mean SUVmax by disease site；Overall Mean SUVmax by cohort；Percent of lymphoma lesions detected；Frequency and severity of treatment-emergent adverse events
NHL受试者将在CD19靶向CAR-T 治疗前后接受64Cu-GRIP B PET检查。3名受试者于治疗后第8天进行PET检查，3名于第15天（±3天）检查，另3名于第22天（±3天）检查。治疗后PET检查后可选取软组织病灶进行活检。末次PET扫描后随访12个月。
NHL受试者将在CD19靶向CAR-T 治疗前后接受64Cu-GRIP B PET检查；治疗后检查时间点根据队列1中64Cu-GRIP B摄取情况选择。治疗后PET检查后可选取软组织病灶进行活检。末次PET扫描后随访12个月。
以上邮箱 / 电话是登记库里的申办方联系方式，通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
这是一项I/Ib期显像研究，评估64Cu-GRIP B正电子发射断层显像（PET）在接受CD19靶向CAR-T 细胞治疗的复发/难治性非霍奇金淋巴瘤（NHL）患者中的应用。64Cu-GRIP B是一种靶向颗粒酶B的铜-64标记限制性相互作用肽。本研究拟开展首批针对淋巴瘤患者的64Cu-GRIP B PET显像。该示踪剂旨在检测肿瘤微环境中活化免疫细胞分泌的细胞外颗粒酶B，可能有助于识别能够从CD19靶向CAR-T 治疗中获得持久应答的肿瘤。
This is a phase I/Ib imaging study of granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B (64Cu-GRIP B) Positron Emission Tomography (PET) in patients with relapsed/refractory non-Hodgkin's lymphoma (NHL) receiving CD19-directed Chimeric antigen receptor T cells (CAR-T) therapy. The proposed study represents the first-ever lymphoma patient imaging studies with 64Cu-GRIP B PET. The tracer is designed to detect extracellular granzyme B as it is secreted by activated immune cells in the tumor microenvironment, which may highlight tumors that will exhibit a durable response to Cluster of Differentiation 19 (CD19)-directed CAR T-cell therapy.
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