肿瘤细胞治疗研究
英文原题：DLL3 CAR-T Therapy Targeting Brain Tumors
这是一项 I/II 期注册临床试验，评估 T 细胞治疗胶质母细胞瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 30 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT07180927。
不限性别 · ≥ 2 Years 且 ≤ 70 Years
纳入标准： 1. 能够理解并愿意提供书面知情同意。 2. 年龄≥2岁且≤70岁。 3. 复发或难治性脑肿瘤患者，且有可测量病灶。患者已接受标准治疗，如最大范围切除联合放化疗（约54至60 Gy及替莫唑胺）。白细胞单采时不得使用地塞米松，或每日剂量≤4 mg。 4. Karnofsky评分≥60。 5. 预期生存期>3个月。 6. 骨髓、肝、肾功能良好：中性粒细胞绝对计数≥1,500/mm³；血红蛋白>10 g/dL；血小板>100,000/mm³；胆红素<正常值上限（ULN）的1.5倍；ALT或AST<ULN的2.5倍；肌酐<ULN的1.5倍。 7. 外周血淋巴细胞绝对计数>0.8×10^9/L。 8. 心功能良好。 9. 患者愿意遵从医生指示。 10. 有生育能力女性（15至49岁）须在研究开始前7天内妊娠试验阴性；有生育能力的男性和女性患者须同意在研究期间及研究结束后3个月内采取避孕措施。 排除标准： 1. 本研究开始前4周内植入过Gliadel，或当前接受抗体类治疗。 2. HIV阳性。 3. 未控制的结核感染。 4. 有自身免疫性疾病史，或患有需长期使用类固醇或免疫抑制治疗的其他疾病。 5. 有过敏性疾病史，或对免疫细胞或研究产品辅料过敏。 6. 正在参加其他免疫细胞临床研究；或研究者认为患者不符合资格或无法遵守研究要求。
Inclusion Criteria: 1. abilities to understand and the willingness to provide written informed consent; 2. patients are ≥ 2 and ≤ 70 years old; 3. recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis; 4. Karnofsky performance score (KPS) ≥ 60; 5. life expectancy \>3 months; 6. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin \> 10 g/dL; platelets \> 100000 /mm\^3; Bilirubin \< 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5×ULN; creatinine \< 1.5×ULN; 7. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L; 8. satisfactory heart functions; 9. patients must be willing to follow the instructions of doctors; 10. women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study. Exclusion Criteria: 1. a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies; 2. HIV positive; 3. tuberculosis infection not under control; 4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies; 5. history of allergic disease, or allergy to immune cells or study product excipients; 6. patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with 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：Number of patients with adverse events. · Determine the toxicity profile the 4SCAR DLL3 cells with Common Toxicity Criteria for Adverse Effects version 4.0 · 6 months
次要终点：Anti-tumor effects；Anti-tumor effects；The expansion of 4SCAR DLL3 T cells；The persistence of 4SCAR DLL3 T cells
按每千克体重10^6个细胞的剂量经静脉输注4SCAR-DLL3 T细胞。
本研究旨在评估Delta样配体3（DLL3）特异性CAR-T细胞疗法用于DLL3阳性脑肿瘤患者（包括胶质母细胞瘤和弥漫性内生性脑桥或中线胶质瘤，DIPG/DMG）的可行性、安全性和疗效。研究还将进一步了解抗DLL3 CAR-T细胞在患者体内的功能和持续性。
The purpose of this study is to assess the feasibility, safety and efficacy of Delta-like ligand 3 (DLL3)-specific CAR-T cell therapy in patients with DLL3 positive brain tumors including glioblastomas and diffused intrinsic pontine or midline gliomas (DIPG or DMG). Another goal of the study is to learn more about the function of the anti-DLL3 CAR-T cells and their persistency in patients.
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