肿瘤细胞治疗研究
英文原题：An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors
这是一项早期 I 期注册临床试验，评估细胞治疗用于实体瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 18 例。试验地点：中国 · 合肥（共 1 个中心，其中中国 1 个）。登记号：NCT07680257。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： • 愿意签署知情同意书（ICF），并遵守预定访视及相关程序。 • 男性或女性，年龄18至75岁。 • 细胞学或组织学确诊晚期恶性实体瘤，且CLDN18.2中至高表达。 • 局部晚期或转移性实体瘤，标准治疗失败、难治或存在标准治疗禁忌。 • ECOG体能状态评分0至1。 • 预期生存期≥3个月。 • 器官和骨髓功能足够。 排除标准： • 存在活动性中枢神经系统转移或浸润。 • 既往接受过骨髓或器官移植（包括但不限于肝移植），或正在等待移植。 • 既往或同时患有其他恶性肿瘤；筛查前至少2年已治愈且无复发的宫颈原位癌、非浸润性基底细胞或鳞状细胞皮肤癌、根治手术后的局部晚期前列腺癌、或根治手术后的导管原位癌患者可能符合资格。 • 存在感染性疾病。 • 既往抗肿瘤治疗所致不良事件尚未恢复至1级或基线（脱发、2级周围神经病变及激素替代治疗下稳定的甲状腺功能减退除外）。 • 筛查前1个月内接种过减毒活疫苗，或计划在研究期间接种减毒活疫苗。 • 筛查前1个月内接受过重大手术（肝占位活检除外），或计划在研究期间接受重大手术。
Inclusion Criteria: * Willing to sign the Informed Consent Form (ICF) and comply with predefined visits and related procedures; * Age 18 to 75, male or female; * Cytology or histology confirmed advanced malignant solid tumors, with moderate to high expression of CLDN18.2; * Locally advanced or metastatic solid tumors that are failed of, or refractory to, or contraindicated for standard of care; * ECOG PS 0-1; * The life expectency ≥ 3 months; * Has sufficient organ and bone marrow function. Exclusion Criteria: * Have active central nervous system metastases or infiltration; * Has previously received a bone marrow or organ transplant (including, but not limited to, a liver transplant) or is awaiting a transplant; * History of or concurrent other malignancies (cured cervical carcinoma in situ with no recurrence within at least 2 years prior to screening, non-invasive basal cell or squamous cell carcinoma of the skin, locally advanced prostate cancer treated with radical surgery, or post-radical surgery ductal carcinoma in situ may be eligible for the study). * Infectious disease; * Adverse events caused by prior anti-tumor therapy that have not resolved to grade 1 or baseline, except for alopecia, grade 2 peripheral neuropathy, and stable hypothyroidism with hormone replacement therapy; * Have received live attenuated vaccine within one month before screening, or plan to receive live attenuated vaccine during the study; * Have major surgery (except liver space-occupying biopsy) within one month before screening, or have planned major surgery during the study.
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：DLT · DLT incidence within 24 days after infusion of SUV2208A. · within 24 days from Day 0；AE/SAE · The incidence, severity, and corelaton of adverse events (AE) and serious adverse events (SAE). · within 2 years from Day 0
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这是一项开放标签、单次/多次给药的探索性临床研究，旨在评估自体人源化抗Claudin 18.2嵌合抗原受体T细胞用于晚期实体瘤的安全性、疗效和药代动力学。
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
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