肿瘤细胞治疗研究
英文原题：A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening
这是一项早期 I 期注册临床试验，评估 BCMA 细胞治疗用于相关疾病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 50 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT07395479。
不限性别 · ≥ 18 Years
纳入标准： * 年龄≥18岁。 * 经组织学确诊的晚期血液系统恶性肿瘤（如多发性骨髓瘤、淋巴瘤）或实体瘤（如小细胞肺癌），且疾病复发或难治。 * 肿瘤细胞表达相应队列要求的靶点（如BCMA、GPRC5D、DLL3）。 * 血液系统恶性肿瘤患者ECOG体能状态评分0–2分，实体瘤患者0–1分；预期寿命≥3个月。 * 器官功能充分（如肌酐清除率≥45 mL/min、LVEF≥45%）。 * 有生育能力者必须同意在研究期间及给药后1年内采取有效避孕措施。 * 已签署知情同意书。 排除标准： * 活动性、未控制的感染。 * 活动性中枢神经系统转移或受累。 * 首次研究给药前规定时间内接受过抗癌治疗、放疗或研究性治疗。 * 严重心脏或肺部疾病（如NYHA心功能Ⅲ/Ⅳ级心力衰竭），或严重肝肾功能损害。 * 活动性乙肝、丙肝、HIV或梅毒感染。 * 既往在规定时间窗内接受异基因造血干细胞移植，或患有活动性移植物抗宿主病。 * 妊娠或哺乳期。 * 对研究产品任何成分有严重过敏史。 * 研究者认为会增加风险或干扰研究结果的其他任何情况。
Inclusion Criteria: * Age ≥ 18 years. * Histologically confirmed advanced hematological malignancies (e.g., multiple myeloma, lymphoma) or solid tumors (e.g., small cell lung cancer) that are relapsed or refractory. * Tumor cells express the relevant target (e.g., BCMA, GPRC5D, DLL3) as required for the specific cohort. * ECOG performance status 0-2 (hematological malignancies) or 0-1 (solid tumors) and life expectancy ≥ 3 months. * Adequate organ function (e.g., creatinine clearance ≥45 mL/min, LVEF ≥45%). * Patients of childbearing potential must agree to use effective contraception during the study and for 1 year after dosing. * Signed informed consent form. Exclusion Criteria: * Active, uncontrolled infection. * Active central nervous system metastases or involvement. * Prior anticancer therapy, radiotherapy, or investigational therapy within specified timeframes before the first study dose. * Severe cardiac or pulmonary disease (e.g., NYHA Class III/IV heart failure), severe hepatic or renal impairment. * Active Hepatitis B, Hepatitis C, HIV, or syphilis infection. * Prior allogeneic hematopoietic stem cell transplantation (within specified window) or active graft-versus-host disease. * Pregnancy or lactation. * History of severe allergy to any components of the investigational product. * Any other condition deemed by the investigator to increase risk or interfere with study results.
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：Incidence of Dose-Limiting Toxicities (DLTs) · Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 28 days post-infusion. · Within 28 days after the first infusion；Maximum Tolerated Dose (MTD) · To determine the MTD of V001 Injection. · During the dose-escalation phase (approximately 12 months)；Incidence of Adverse Events (AEs) · Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0. · From signing ICF until 24 months after the last infusion.
次要终点：Objective Response Rate (ORR)；Duration of Response (DOR)；Progression-Free Survival (PFS)；Overall Survival (OS)；Peak concentration of CAR-T cells in peripheral blood；time to peak of CAR-T cells in peripheral blood；AUC of CAR-T cells in peripheral blood
针对B细胞相关血液系统恶性肿瘤患者，单药静脉输注V001-BCMA。剂量队列：1×10^8 TU、2×10^8 TU、≤4×10^8 TU和≤8×10^8 TU。
针对B细胞相关血液系统恶性肿瘤患者，单药静脉输注V001-GPRC5D。剂量队列：1×10^8 TU、2×10^8 TU、≤4×10^8 TU和≤8×10^8 TU。
针对小细胞肺癌患者，单药静脉输注V001-DLL3。剂量队列：1×10^8 TU、2×10^8 TU、≤4×10^8 TU和≤8×10^8 TU。
针对B细胞相关血液系统恶性肿瘤患者，单药静脉输注V001-FcRH5。剂量队列：1×10^8 TU、2×10^8 TU、≤4×10^8 TU和≤8×10^8 TU。
这是一项单臂、开放标签、单中心、剂量递增Ⅰ期平台研究，旨在评估体内CAR-T疗法（V001注射液，靶向BCMA、GPRC5D、DLL3、FcRH5等）用于晚期恶性肿瘤患者的安全性、耐受性、初步疗效、药代动力学和药效学。
This is a single-arm, open-label, single-center, dose-escalation Phase I platform study designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of an in vivo CAR-T therapy (V001 Injection, targeting BCMA, GPRC5D, DLL3,FcRH5, etc.) in patients with advanced malignant tumors.
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