肿瘤细胞治疗研究
英文原题：A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)
这是一项 II 期注册临床试验，评估细胞治疗用于急性淋巴细胞白血病、淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 125 例。试验地点：美国 · 杜阿尔特、洛杉矶、丹佛、华盛顿特区（共 18 个中心）。登记号：NCT06514794。
不限性别 · ≥ 6 Months
关键纳入标准： • 疾病：符合世界卫生组织（WHO）分类定义的T-ALL或T-LBL，且为复发/难治性或MRD阳性。 • 年龄≥6个月；器官功能充分。 • 筛查时东部肿瘤协作组（ECOG）体能状态为0或1，或Karnofsky体能状态评分≥70。 关键排除标准： • 既往接受过任何抗CD7治疗。 • 失代偿性溶血性贫血。 • 存在需全身免疫抑制治疗的2至4级急性或广泛型慢性移植物抗宿主病（GvHD）。无需免疫抑制治疗的1级GvHD，或仅接受局部治疗的2级皮肤GvHD可接受。
Key Inclusion Criteria: * Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive * Age: Lower age limit of ≥ 6 months; adequate organ function * Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening. Key Exclusion Criteria: * Prior treatment with any anti-CD7 therapy. * Patients with decompensated hemolytic anemia. * Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
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：R/R Cohort - Composite Complete Response Rate · CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi) · 24 months；MRD Pos Cohort - Response Rate · Defined as the efficacy of WU-CART-007 to induce complete MRD negative response · 24 months
一种靶向CD7的嵌合抗原受体（CAR）T细胞产品。 淋巴细胞清除治疗
T-RRex研究旨在评估WU-CART-007治疗复发/难治性T细胞急性淋巴细胞白血病（T-ALL）/淋巴母细胞淋巴瘤（LBL）的疗效，并评估其诱导微小残留病（MRD）阴性完全缓解的能力。
The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response
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