肿瘤细胞治疗研究
英文原题：A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC
⚠ 该试验的登记信息已有 17 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I 期注册临床试验，评估细胞治疗用于肾细胞癌的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 28 例。登记号：NCT06870279。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： * 1. 年龄18至75岁。 * 2.ECOG 0-1分。 * 3. 预期生存时间超过3个月。 * 4. 经组织学或细胞学确诊的晚期ccRCC患者，至少一线治疗后复发或转移。 * 5. IHC：CD70阳性。 * 6. 根据RECIST 1.1版，基线时至少有一个可测量病灶。 * 7. 重要器官功能基本正常： * 8. 育龄妇女妊娠试验应为阴性，男女双方均同意使用有效避孕措施。 排除标准： * 1. 前一个月内使用过细胞治疗。 * 2. 过去2年内患有其他恶性肿瘤的受试者，但基底细胞癌或鳞状皮肤癌、浅表性膀胱癌和原位乳腺癌已完全治愈且无需后续治疗者除外。 * 3. 患有软脑膜转移或中枢神经系统转移，以及有明显症状的明确中枢神经系统基础疾病的患者。 * 4. 细胞输注前2周内5个药物半衰期内接受过免疫治疗、靶向药物治疗或化疗。 * 5. 活动性乙型肝炎、HIV阳性及HCV阳性。 * 6. 活动性感染或不可控制的感染。 * 7. 不可控制或严重的心脏疾病。 * 8. 不稳定的呼吸系统疾病，包括间质性肺炎。 * 9. 未控制的腹水和胸腔积液。 * 10.已知患有活动性或未控制的自身免疫性疾病，如克罗恩病、类风湿关节炎、系统性红斑狼疮等。 * 11.正在使用全身性类固醇或类固醇吸入剂进行治疗的患者。 * 12.妊娠或哺乳期女性受试者。 * 13.研究者认为不适合参加本研究的其他情况。
Inclusion Criteria: * 1\. Age 18 to 75 years. * 2.ECOG 0-1 points. * 3\. The expected survival time is more than 3 months. * 4\. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment. * 5\. IHC: CD70 positive. * 6\. At least one measurable lesion at baseline per RECIST version 1.1. * 7\. The functions of important organs are basically normal: * 8\. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception. Exclusion Criteria: * 1\. Use of cell therapy within the previous one month. * 2\. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment. * 3\. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms. * 4\. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion. * 5\. Active hepatitis B, HIV positive and HCV positive. * 6\. Active infection or uncontrollable infection. * 7\. Uncontrollable or significant heart disease. * 8\. Unstable respiratory diseases, including interstitial pneumonia. * 9\. Uncontrolled ascites and pleural effusion. * 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. * 11.Subjects who are using systemic steroids or steroid inhalers for treatment. * 12.Pregnant or lactating female subjects. * 13.Other investigators deem it unsuitable to participate in 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：Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) · Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0. · Day 28 after CGC738 infusion
次要终点：ORR；DCR；AEs
CAR-NKT细胞治疗
这是一项I期、开放标签、单臂研究，旨在评估CGC738治疗晚期透明细胞肾细胞癌（ccRCC）的疗效、安全性和PK。
This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).
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