肿瘤细胞治疗研究
英文原题：P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
这是一项 I 期注册临床试验，评估 CAR-T 细胞治疗乳腺癌、卵巢癌、非小细胞肺癌的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 180 例。试验地点：美国 · 尔湾、洛杉矶、圣迭戈、旧金山（共 14 个中心）。登记号：NCT05239143。
不限性别 · ≥ 18 Years
纳入标准： * 男性或女性，年龄≥18岁，预期寿命>3个月； * 确诊不可切除、局部晚期或转移性上皮来源癌症； * 最近一次治疗期间或治疗后疾病进展，或对当前治疗出现不耐受/毒性，或不适合/拒绝其他现有治疗，且有可测量疾病； * ECOG体能状态0–1或Karnofsky体能状态≥70%； * 主要器官功能达到预设要求； * 有可用的存档肿瘤组织，或同意接受活检； * 愿意避孕；筛查时及开始淋巴细胞清除化疗或研究药物前妊娠试验阴性； * 已从既往治疗毒性中恢复。 排除标准： * 静脉通路不足； * 除本研究肿瘤外，存在活动性第二恶性肿瘤，且无病生存不足5年；低风险肿瘤（如非转移性基底细胞癌或鳞状细胞皮肤癌）除外； * 妊娠或哺乳； * 既往或当前有自身免疫性疾病； * 有严重中枢神经系统（CNS）疾病史，如卒中、癫痫； * 活动性全身感染（病毒、细菌或真菌）； * NYHA Ⅲ/Ⅳ级心衰、不稳定型心绞痛、心肌梗死史或显著心律失常； * 存在会妨碍安全参加研究和/或遵循方案的精神或医学疾病； * 开始淋巴细胞清除前2周内使用抗癌药物； * P-MUC1C-ALLO1给药前2周内接受免疫抑制药物，和/或预计研究期间需要此类药物； * P-MUC1C-ALLO1给药前1周内接受全身性皮质类固醇治疗，或预计研究期间需要此类治疗； * 已知CNS转移或有症状的CNS受累； * 有严重肝病史或活动性肝病； * 已知有HLH/MAS遗传易感史； * 开始淋巴细胞清除治疗前4周内接受抗癌单克隆抗体治疗。
Inclusion Criteria: * Males or females, Subjects ≥18 years with life expectancy \>3 months * Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer * Must have progressed during or after last therapy, developed intolerance/toxicity to current treatment, or ineligible or refused other existing treatment options, and have measurable disease * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70% * Must have adequate vital organ function within pre-determined parameters * Must have archived tumor tissue available or consent to a biopsy collection * Must be willing to practice birth control * Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration * Must have recovered from toxicities due to prior therapies Exclusion Criteria: * Has inadequate venous access * Has an active second malignancy (not disease free for at least 5 years) in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma * Is pregnant or lactating * Has a history of or active autoimmune disease * Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy * Has an active systemic (viral, bacterial, or fungal) infection * Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia * Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol * Has received anticancer medications within 2 weeks of the time of initiating lymphodepletion * Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study * Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study * Has known CNS metastases or symptomatic CNS involvement * Has a history of significant liver disease or active liver disease * Has a history of known genetic predisposition to HLH/MAS * Has received anti-cancer monoclonal antibody therapy within 4 weeks of initiating LD therapy
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：Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 · Number of subjects with a dose limiting toxicity (DLT) · Baseline through Day 28；Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1 · Frequency and severity of adverse events · Baseline through 15 years；Evaluate the preliminary efficacy of P-MUC1C-ALLO1 · According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR) · Baseline through 15 years
在淋巴细胞清除方案1后，单次静脉输注CAR-T细胞，进行单次递增剂量队列；必要时可给予Rimiducid。
在淋巴细胞清除方案1后，按周期单次静脉输注CAR-T细胞，进行递增剂量队列；必要时可给予Rimiducid。
在淋巴细胞清除方案2后，单次静脉输注CAR-T细胞，进行单次递增剂量队列；必要时可给予Rimiducid。
在淋巴细胞清除方案2后，按周期单次静脉输注CAR-T细胞，进行递增剂量队列；必要时可给予Rimiducid。
在淋巴细胞清除方案1后，单次静脉输注CAR-T细胞，进行A1递增剂量队列；必要时可给予Rimiducid。
在指定淋巴细胞清除方案后，单次静脉输注CAR-T细胞，进行单次递增剂量队列；必要时可给予Rimiducid。
在指定淋巴细胞清除方案后，按周期单次静脉输注CAR-T细胞，进行递增剂量队列；必要时可给予Rimiducid。
在指定淋巴细胞清除方案后，单次静脉输注CAR-T细胞，进行递增剂量队列；必要时可给予Rimiducid。
一项Ⅰ期、开放标签、剂量递增并设扩展队列的研究，在晚期或转移性上皮来源实体瘤成人患者中评估P-MUC1C-ALLO1。研究涉及但不限于方案所列肿瘤类型。
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.
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