肿瘤细胞治疗研究
英文原题：U87 CAR-T in Patients With Advanced Head and Neck Tumors
⚠ 该试验的登记信息已有 24 个月未更新， 页面上显示的「招募中」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，评估自体 CAR-T 细胞治疗恶性肿瘤、头颈部肿瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 20 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT06614686。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： 1. 受试者已提供知情同意，理解研究风险和获益，并愿意完成研究流程。 2. 签署知情同意时年龄18～70岁（含），男女均可。 3. ECOG体能状态评分0～1分。 4. 预期生存期至少12周。 5. 组织学或细胞学确诊为晚期头颈部恶性肿瘤，且无有效标准治疗可用。 6. 知情同意前2年内或近期活检肿瘤样本中Trop2表达阳性（强度≥2+，表达率≥40%）。 7. 根据RECIST 1.1至少有1个可测量肿瘤病灶。 8. 有适合单核细胞采集的静脉通路。 9. 主要器官功能充足。 10. 有生育能力的女性筛选时妊娠试验阴性；有性生活的受试者同意在研究期间及末次CAR-T输注后1年内采取有效避孕措施。 排除标准： 1. 既往抗癌治疗的洗脱期不足，未达到白细胞单采要求。 2. 白细胞单采前4周内接种过活疫苗或减毒疫苗，或计划在研究期间接种。 3. 白细胞单采前4周内接受过重大手术或遭受重大创伤，或计划在研究期间接受重大手术。 4. 既往接受过Trop2靶向CAR-T／TCR-T细胞治疗或其他细胞治疗，或治疗性癌症疫苗。 5. 存在研究者判定不符合入组条件的症状性脑转移或软脑膜转移。 6. 存在需要静脉抗感染治疗的活动性感染。 7. HBsAg、HBeAg、HBV-DNA、HCV-Ab、HCV-RNA、TP-Ab、HIV抗体阳性，或EBV-DNA、CMV-DNA升高。 8. 原发性免疫缺陷或活动性自身免疫性疾病。 9. 白细胞单采前7天内长期使用全身性糖皮质激素或免疫抑制剂；局部、眼用、关节腔内、鼻内或吸入治疗除外。 10. 既往治疗相关不良反应尚未恢复至CTCAE 5.0版≤1级或方案规定水平；不影响安全风险的毒性除外。 11. 有间质性肺病、间质性肺炎、肺部炎症或大范围胸部放疗史。 12. 对蛋白类药物或多种药物过敏。 13. 研究药物使用前5年内患有其他未治疗的恶性肿瘤；有免疫缺陷、造血干细胞／器官移植史；存在无法控制的第三间隙积液。 14. 有严重心血管或脑血管疾病史，包括NYHA≥Ⅱ级心力衰竭、未控制的高血压或近期严重事件。 15. 妊娠或哺乳期女性。 16. 有无法控制的精神疾病史。 17. 研究者认为不适合参加研究的其他情况。
Inclusion Criteria:
1. Subjects have provided informed consent, understanding the study\'s risks and benefits, and are willing to complete the study procedures.
2. Age between 18 and 70 years old at the time of consent, inclusive, and open to both genders.
3. ECOG performance status of 0-1.
4. Anticipated survival of at least 12 weeks.
5. Histologically or cytologically confirmed advanced malignant head and neck cancer patients with no effective standard treatments available
6. Positive Trop2 expression (intensity ≥2+, expression rate ≥40%) in tumor tissue samples within 2 years prior to consent or from recent biopsies.
7. At least one measurable tumor lesion according to RECIST 1.1.
8. Suitable venous access for mononuclear cell collection.
9. Adequate major organ function.
10. Negative pregnancy test for women of reproductive age at screening; sexually active subjects must agree to use effective contraception during the study and for one year after the last CAR-T cell infusion.
Exclusion Criteria:
1. Inadequate washout period from prior anti-cancer treatments before leukapheresis.
2. Receipt of live or attenuated vaccines within 4 weeks prior to leukapheresis or planned receipt during the study.
3. Major surgery or significant trauma within 4 weeks prior to leukapheresis or planned during the study.
4. Previous Trop2-targeted CAR-T/TCR-T cell therapy or other cellular treatments, or therapeutic cancer vaccines.
5. Symptomatic brain metastases or leptomeningeal metastases deemed ineligible by the investigator.
6. Active infection requiring intravenous anti-infective therapy.
7. Positive for HBsAg, HBeAg, HBV-DNA, HCV-Ab, HCV-RNA, TP-Ab, HIV antibodies, or elevated EBV-DNA, CMV-DNA.
8. Primary immunodeficiency or active autoimmune disease.
9. Chronic use of systemic corticosteroids or immunosuppressants within 7 days before leukapheresis, except for local, ophthalmic, intra-articular, intranasal, or inhaled treatments.
10. Prior treatment-related adverse effects not recovered to CTCAE v5.0 grade ≤1 or specified levels, except for non-safety risk toxicities.
11. History of interstitial lung disease, interstitial pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy.
12. Allergy to protein drugs or multiple medications.
13. Other untreated malignancies within 5 years prior to study drug use. History of immune deficiency, hematopoietic stem cell/organ transplantation. Uncontrollable third-space fluid accumulation.
14. Severe cardiovascular or cerebrovascular disease history, including NYHA class ≥II heart failure, uncontrolled hypertension, or recent severe events.
Pregnant or breastfeeding women.
15. Uncontrollable psychiatric history.
16. Other conditions deemed unsuitable for study participation by the investigator.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 Adverse events after U87 CAR-T cells infusion [Safety and Tolerability] · An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) · 28 days post administration of CAR-T-cells
次要终点：Pharmacokinetics of U87 CAR-T cells；Pharmacokinetics of U87 CAR-T cells；Pharmacokinetics of U87 CAR-T cells；Pharmacodynamics of U87 CAR-T cells；Objective Response Rate (ORR), as assessed by Investigators；Duration of response (DOR), as assessed by Investigators；Overall survival (OS)；Progression-free survival (PFS), as assessed by Investigators
分为两个阶段：剂量递增和剂量扩展。
这是一项单臂、开放标签临床研究，旨在评估U87注射液用于晚期头颈部恶性肿瘤患者的安全性、耐受性和疗效。
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.
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