肿瘤细胞治疗研究
英文原题：CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
⚠ 该试验的登记信息已有 21 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 CAR-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 10 例。试验地点：中国 · 广州（共 1 个中心，其中中国 1 个）。登记号：NCT06752785。
不限性别 · ≥ 1 Year 且 ≤ 18 Years
纳入标准： 1. 父母或法定监护人充分了解本研究并签署知情同意书（ICF），愿意遵守并能够完成所有检查流程。 2. 筛选时年龄1～18岁的中国儿童，性别不限，体重≥10 kg。 3. 骨髓检查证实诱导缓解后第46天MRD仍阳性。 4. 筛选前3个月内骨髓（BM）或外周血（PB）肿瘤细胞表达CD19/CD22。 5. 器官功能良好，符合以下标准：ALT≤正常值上限（ULN）的5倍；总胆红素≤ULN的2倍（Gilbert综合征≤ULN的3倍）；未吸氧时呼吸困难≤1级且血氧饱和度>95%；左心室射血分数（LVEF）≥50%；血清肌酐≤ULN的1.5倍。 6. Karnofsky评分（年龄≥16岁）≥70分，或Lansky评分（年龄<16岁）≥50分。 7. 预期生存期至少12周。 8. 有适当静脉通路（用于单采或静脉采血），且无其他血细胞分离禁忌证。 排除标准： 1. 患有遗传性疾病，唐氏综合征除外。 2. 有其他恶性肿瘤史或同时患有其他恶性肿瘤。 3. 符合以下任一情况：乙肝表面抗原（HBsAg）阳性或HBV DNA定量高于ULN；丙肝抗体（HCV Ab）阳性且HCV RNA定量高于ULN；HIV抗体阳性；梅毒螺旋体抗体（TP-Ab）阳性；EBV DNA高于ULN；巨细胞病毒DNA高于ULN。 4. 存在或疑似存在未控制、或需要静脉药物治疗的真菌、细菌、病毒或其他感染。 5. 筛选前21天内禁止使用长效G-CSF，筛选前7天内禁止使用短效G-CSF。 6. 存在活动性中枢神经系统白血病。 7. 对白蛋白或氨基糖苷类抗生素过敏。 8. 曾接受器官移植（造血干细胞移植除外）。 9. 筛选前3个月内参加过其他干预性临床研究并接受活性试验药物，或计划在整个研究期间参加其他临床试验／接受方案规定以外的抗肿瘤治疗。 10. 因重要器官功能受损而无法耐受化疗及细胞因子风暴。 11. 研究者认为不适合参加本临床试验的其他情况。
Inclusion Criteria: 1. Parents or legal guardians fully understand, are informed of this study and sign the informed consent form (ICF); are willing to follow and can complete all test procedures. 2. Chinese children aged 1-18 years old at the time of screening, regardless of gender, with a body weight ≥ 10 kg. 3. Bone marrow examination confirms that MRD is still positive on the 46th day after induction remission. 4. Tumor cells in the bone marrow (BM) or peripheral blood (PB) express CD19/CD22 within 3 months before screening. 5. Good organ function, which needs to meet the following criteria: (1)ALT ≤ 5 times the upper limit of normal value (ULN); (2)total bilirubin ≤ 2 times ULN (Gilbert's syndrome ≤ 3 times ULN); (3)without \> grade 1 dyspnea when not inhaling oxygen, and oxygen saturation \> 95%; (4)left ventricular ejection fraction (LVEF) ≥ 50%; (5)serum creatinine ≤ 1.5 times ULN. 6. Karnofsky score (≥ 16 years old) ≥ 70 or Lansky (\< 16 years old) score ≥ 50. 7. Expected survival period of at least 12 weeks. 8. Have sufficient venous access (for apheresis or venous blood sampling), and have no other contraindications for blood cell separation. Exclusion Criteria: 1. Have genetic diseases, except Down syndrome. 2. Have a history of other malignancies or have other malignancies simultaneously. 3. Meet any of the following conditions: (1)hepatitis B surface antigen (HBsAg) positive or HBV DNA quantification higher than the upper limit of normal value; (2)hepatitis C antibody (HCV Ab) positive and HCV RNA quantification higher than the upper limit of normal value; (3)human immunodeficiency virus antibody (HIV-Ab) positive; (4)Treponema pallidum antibody (TP-Ab) positive; (5)EBV DNA higher than the upper limit of normal value; (6)cytomegalovirus DNA higher than the upper limit of normal value. 4. Have or are suspected to have uncontrolled or require intravenous drug treatment for fungal, bacterial, viral or other infections. 5. Long-acting G-CSF is prohibited within 21 days before screening, and short-acting G-CSF is prohibited within 7 days before screening. 6. Have active central nervous system leukemia. 7. Are allergic to albumin and aminoglycoside antibiotics. 8. Have undergone organ transplantation (except hematopoietic stem cell transplantation). 9. Have participated in other interventional clinical studies within 3 months before screening (received active test drug treatment), or intend to participate in another clinical trial or receive anti-tumor treatment other than that specified in the protocol during the entire study period. 10. Cannot tolerate chemotherapy and cytokine storm due to impaired function of important organs. 11. Other situations that the investigator deems not suitable for participating in this clinical trial.
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：Validity exploration · According to the efficacy evaluation criteria for ALL in the "NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V5)", the complete remission(CR) rate will be evaluated at 1 year after CAR-T treatment.CR is generally measured in percentage(%). · One year after CAR-T treatment
MRD阳性B系急性淋巴细胞白血病儿童；接受CD19/CD22 CAR-T治疗。
本研究将在诱导缓解后仍MRD阳性的儿童患者中开展CD19/CD22双靶点CAR-T治疗；CAR-T细胞发挥作用后继续给予化疗。本研究拟采用逆转录病毒载体构建的CD19/CD22串联CAR-T细胞治疗MRD阳性ALL。CAR-T细胞由深圳细胞谷提供。美国斯坦福大学医学院研究团队已证明，在封闭系统中制备双特异性CD19/CD22.BB.z-CAR T细胞具有可行性和安全性，并且该疗法治疗CAR19耐药B-ALL及大B细胞淋巴瘤（LBCL）显示出较高临床活性。研究者希望通过本安全性和疗效研究扩大CAR-T细胞在MRD阳性B-ALL中的应用，显著改善此类儿童患者的预后。
In this study, CD19/CD22 dual-target CAR-T therapy will be carried out among children patients who are still positive after induction remission, and subsequent chemotherapy will continue after CAR-T cells exert their functions. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19/CD22 to treat MRD-positive ALL. The CAR-T cells were provided by Shenzhen Cell Valley. The results of the research team from Stanford University School of Medicine in the United States have already demonstrated the feasibility and safety of producing bispecific CD19/CD22.BB.z-CAR T cells in a closed system as well as the high clinical activity shown in the treatment of CAR19-resistant B-ALL (B-lineage acute lymphoblastic leukemia) and LBCL (Large B-cell lymphoma). The investigators look forward to expanding the application of CAR-T cells in MRD positive B-ALL through this clinical study on safety and efficacy and greatly improving the prognosis of children patients with this type of B-ALL.
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