肿瘤细胞治疗研究
英文原题：Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL.
这是一项 II 期注册临床试验，评估自体 CAR-T 细胞治疗淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 38 例。登记号：NCT07244380。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 受试者或监护人自愿提供知情同意。 2. 既往接受多线治疗、复发或难治且缺乏有效替代治疗的T-LBL/ALL患者。 3. 筛查时须通过流式细胞术（骨髓或外周血样本）和/或免疫组织化学（IHC，髓外病灶活检）记录肿瘤细胞CD7阳性。 4. 若筛查时外周血检测到恶性细胞，流式细胞术须证实其CD4阴性、CD8阴性（双阴性）免疫表型。 5. 男性或女性，年龄18至75岁（含两端）。 6. ECOG体能状态评分0–2。 7. 预期生存期>12周。 排除标准： 1. 过去6个月内接受过异基因造血干细胞移植。 2. 筛查时存在需要全身治疗的活动性或未控制感染，轻度泌尿生殖道和上呼吸道感染除外。 3. 签署知情同意书（ICF）前4周内参加其他临床试验，或签署ICF时距离既往研究药物末次给药尚未超过5个半衰期（以上述较长时限为准）。 4. 既往接受过CAR-T细胞或其他基因修饰细胞治疗。 5. 筛查前4周内存在急性GVHD或中重度慢性GVHD，或输注前4周内接受GVHD全身药物治疗。 6. 签署ICF前4周内接受过大范围放疗；研究期间可允许针对非靶病灶的症状姑息性放疗。 7. 妊娠或哺乳期女性。 8. 研究者判断会增加受试者风险或影响试验结果解释的任何情况。
Inclusion Criteria: * 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL/ALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and/or by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time\>12 weeks. Exclusion Criteria: * 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections； 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe chronic GVHD (cGVHD) within 4 weeks prior to screening, or those who have received systemic pharmacologic therapy for GVHD within 4 weeks prior to infusion; 6.Patients who have received extensive radiotherapy within 4 weeks prior to ICF signing, with the exception of non-target lesion radiotherapy administered for symptomatic palliation that may be permitted during the study period; 7.Women who are pregnant or lactating; 8.Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial 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：Objective response rate after S101 infusion [Effectiveness] · Independent Review Committee (IRC)-assessed ORR at Month 3 post-infusion. · 3 months
自体CD7靶向CAR-T细胞，剂量2×10⁶/kg，单次静脉输注。
评估S101治疗CD7阳性复发或难治性T细胞淋巴母细胞淋巴瘤/急性淋巴细胞白血病（T-LBL/ALL）的疗效和安全性。
To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.
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