肿瘤细胞治疗研究
英文原题：a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL
⚠ 该试验的登记信息已有 19 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/II 期注册临床试验，评估 CD19CAR-T 细胞治疗急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 40 例。试验地点：中国 · 昆明（共 1 个中心，其中中国 1 个）。登记号：NCT04781634。
不限性别 · ≥ 2 Years 且 ≤ 75 Years
纳入标准：签署书面知情同意书；确诊复发/难治性B-ALL，且符合以下任一情况：标准化疗方案失败；完全缓解后复发、属于高危和/或难治性患者；造血干细胞移植后复发。Ph+ ALL患者还须符合：接受标准诱导化疗方案后，TKI治疗未达到完全缓解，或缓解后复发（不能耐受TKI、有TKI禁忌证或对TKI类药物耐药者除外）；有证据显示细胞膜CD19或CD22表达；性别不限，年龄2-75岁；预期生存期>3个月；KPS>60；无严重精神障碍；左心室射血分数≥50%；肝功能充分（ALT/AST≤正常值上限3倍且胆红素≤2倍）；肾功能充分（原登记标准为肌酐清除率≤正常值上限2倍）；肺功能充分（室内空气下血氧饱和度≥92%）；符合单采或静脉采血要求且无其他细胞采集禁忌；能够并愿意遵守访视安排及方案要求。排除标准：既往其他恶性肿瘤；未控制的活动性感染；存在需糖皮质激素治疗的疾病；活动性或慢性GVHD；接受T细胞抑制剂治疗；妊娠或哺乳；研究者认为不适合参加研究或可能影响数据分析的情况（如HIV、HCV感染或静脉药物成瘾）。
Inclusion Criteria: 1. Signed written informed consent 2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients) 4. Evidence for cell membrane CD19 or CD22 expression 5. All genders ages: 2 to 75 years 6. The expect time of survive is above 3 months; 7. KPS\>60 8. No serious mental disorders ; 9. Left ventricular ejection fraction ≥50% 10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 11. Sufficient renal function defined by creatinine clearance≤2 x ULN; 12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 13. With single or venous blood collection standards, and no other cell collection contraindications; 14. Ability and willingness to adhere to the study visit schedule and all protocol requirements. Exclusion Criteria: 1. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD 5. The patients treatment by inhibitor of T cell 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
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：Adverse events that related to treatment · Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) · 2 years；The response rate of CD19 and CD22 prime CAR-T treatment in patients with relapse/refractory B-ALL · The response rate of CD19 and CD22 prime CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline · 6 months
次要终点：Rate of prime CAR-T cells in bone marrow；Rate of prime CAR-T cells in peripheral blood；Quantity of prime CAR copies in bone marrow；Quantity of prime CAR copies in peripheral blood；Rate of CD19 and CD22 positive cells in Bone marrow；Levels of IL-6 in Serum；Levels of IL-10 in Serum；Levels of TNF-α in Serum
患者将接受CD19和CD22 Prime CAR-T细胞治疗。
这是一项单臂研究，旨在评估CD19和CD22靶向Prime CAR-T细胞治疗复发/难治性B-ALL患者的疗效和安全性。
This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL
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