肿瘤细胞治疗研究
英文原题：Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
这是一项分期未标注的注册临床试验，评估细胞治疗用于实体瘤、结直肠癌、非小细胞肺癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 500 例。试验地点：美国 · 吉尔伯特、凤凰城、杜阿尔特、拉霍亚（共 16 个中心）。登记号：NCT04981119。
不限性别 · ≥ 18 Years
关键入排标准（可能还适用其他标准）： 第1部分纳入标准： 1. 病理确诊实体瘤，如结直肠癌（CRC）、非小细胞肺癌（NSCLC）或胰腺癌（PANC），且为转移性、不可切除的局部晚期，或研究者认为两年内有高风险复发为不可治愈疾病。 第1部分排除标准： 1. 过去5年内有其他恶性肿瘤史，但非黑色素瘤皮肤癌、低级别局限性前列腺癌、浅表性膀胱癌、乳腺导管原位癌（CIS）、宫颈CIS或Ⅰ期子宫癌除外； 2. 既往异体干细胞移植； 3. 既往实体器官移植。 第2部分纳入标准： 1. 病理确诊实体瘤，如CRC、NSCLC、胰腺癌、间皮瘤或卵巢癌（OVAC），且为转移性、不可切除的局部晚期，或研究者认为两年内有高风险复发为不可治愈疾病； 2. HLA分型证实生殖系HLA-A*02杂合； 3. 原发肿瘤组织经二代测序（NGS）显示HLA-A*02杂合性缺失（LOH）； 4. ECOG体能状态0或1。 第2部分排除标准： 1. 过去5年内有其他恶性肿瘤史，但非黑色素瘤皮肤癌、低级别局限性前列腺癌、浅表性膀胱癌、乳腺导管原位癌、宫颈CIS或Ⅰ期子宫癌除外； 2. 既往异体干细胞移植； 3. 既往实体器官移植； 4. 计划单采前2周内或3个半衰期内（取较短者）接受任何适应症的抗癌治疗或试验治疗，包括化疗、小分子药物、单克隆抗体或影响骨髓的放疗； 5. 入组时存在已知活动性细菌、病毒、真菌、分枝杆菌、寄生虫或其他感染（甲床真菌感染除外），需要特异治疗，或有需静脉抗菌药（如静脉抗生素）治疗/住院的重要感染； 6. 已知活动性CNS转移；既往治疗过的脑转移患者经医学监查员同意后可参加； 7. 研究者判断其他任何情况会导致受试者无法完成所需研究访视、程序和随访，或无法遵守研究要求。
Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria 1\. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years. Part 1: Key Exclusion Criteria 1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer. 2. Prior allogeneic stem cell transplant. 3. Prior solid organ transplant. Part 2 : Key Inclusion Criteria 1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years. 2. Participants are germline HLA-A\*02 heterozygous confirmed by HLA typing. 3. Primary tumor tissue showing LOH of HLA-A\*02 by NGS testing. 4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status. Part 2: Key Exclusion Criteria 1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer. 2. Prior allogeneic stem cell transplant. 3. Prior solid organ transplant. 4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter. 5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course). 6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement. 7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.
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：Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis · Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study · up to 2 years；Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing · Percentage of participants experiencing LOH will be calculated based on NGS results · Screening
次要终点：Percentage of enrolled participants who experience an adverse event (AE) related to apheresis
研究目的：通过二代测序收集实体瘤患者人类白细胞抗原（HLA）缺失发生频率的信息，并通过单采采集、储存符合条件受试者的自体T细胞，以备将来为其疾病治疗制备CAR-T细胞产品。 研究设计：这是一项非干预性观察研究，评估复发后疾病可能无法治愈的高危实体瘤患者。本研究不实施干预性治疗。肿瘤分析信息可能有助于疾病管理。符合所有条件者可入组并接受白细胞单采。采集的细胞将进行处理和储存；若癌症复发，可用于制备CAR-T细胞治疗。
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
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