肿瘤细胞治疗研究
英文原题：Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL
Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项早期 I 期注册临床试验，评估 CD19CAR-T 细胞治疗相关疾病的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 60 例。登记号：NCT06879262。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准： 1. 患者或其法定监护人自愿参加并签署知情同意书。 2. 年龄18～80岁（含），性别不限。 3. 根据WHO 2016年分类诊断为B细胞急性淋巴细胞白血病或非霍奇金淋巴瘤。 4. 流式细胞术或组织病理学证实CD19或CD22阳性。 5. 诊断为复发／难治性B细胞急性淋巴细胞白血病或非霍奇金淋巴瘤。 6. 主要器官功能良好： （1）肝功能：ALT/AST<正常值上限（ULN）的3倍，总胆红素≤34.2 μmol/L。 （2）肾功能：按Cockcroft-Gault法计算的肌酐清除率≥60 mL/min。 （3）肺功能：血氧饱和度≥95%，且无活动性肺部感染。 （4）心功能：左心室射血分数（LVEF）≥50%；无明显心包积液及有临床意义的心电图异常。 7. 有生育能力的女性筛选时尿液／血液妊娠试验阴性，并同意输注后至少1年采取避孕措施；有生育能力的男性受试者须同意输注后至少1年采用有效屏障避孕措施。 8. ECOG体能状态评分≤1分。 9. 预期生存期>3个月。 排除标准： 1. 哺乳期女性。 2. 入组前4周内患有未控制的感染性疾病。 3. 活动性乙型或丙型肝炎。 4. HIV感染。 5. 患有严重自身免疫性疾病或免疫缺陷病。 6. 属于过敏体质，或对抗体、细胞因子及其他大分子生物制剂过敏。 7. 入组前4周内参加过其他临床试验。 8. 有临床显著中枢神经系统疾病史，例如癫痫、瘫痪、失语、卒中、严重脑外伤、痴呆、帕金森病、小脑疾病或器质性脑综合征。 9. 患有精神疾病。 10. 有药物滥用／成瘾。 11. 使用禁忌药物： （1）糖皮质激素：白细胞采集前7天内，或靶向CD19和CD22的CAR-T 细胞输注前72小时内，使用治疗剂量糖皮质激素（定义为泼尼松或等效剂量>20 mg/日）；生理替代剂量、局部用药和吸入用药允许。 （2）化疗：白细胞采集前2周内接受过挽救化疗。 （3）异基因细胞治疗：白细胞采集前4周内接受过供者淋巴细胞输注。 （4）GVHD治疗：靶向CD19和CD22的CAR-T 细胞输注前4周内接受过抗GVHD治疗。 （5）白细胞采集前6个月内使用过阿仑单抗或克拉屈滨，或前3个月内使用过苯丁酸氮芥或氯法拉滨。
Inclusion Criteria:
* 1\. The patient or their legal guardian voluntarily participates and signs an informed consent form.
2.Age between 18-80 years old (inclusive), with no gender restrictions. 3.Diagnosed with acute B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma according to the WHO 2016 classification.
4.CD19 or CD22 positivity confirmed by flow cytometry or histopathology. 5.Diagnosed with refractory/relapsed B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
6.Good major organ function:
1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L;
2. Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min;
3. Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection;
4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, no clinically significant ECG abnormalities.
7.Women of childbearing age with negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion; male subjects with reproductive capacity must agree to use effective barrier contraceptive methods for at least 1 year after infusion.
8.ECOG score ≤ 1. 9.Life expectancy greater than 3 months.
Exclusion Criteria:
* 1.Women who are breastfeeding. 2.Patients with uncontrollable infectious diseases within 4 weeks before enrollment.
3.Active hepatitis B/C. 4.HIV-infected patients. 5.Patients with severe autoimmune diseases or immunodeficiency diseases. 6.Patients with allergic constitution, allergic to antibodies or cytokines and other large molecule biological drugs.
7.Patients who have participated in other clinical trials within 4 weeks before enrollment.
8.History of clinically significant central nervous system diseases: such as epilepsy, paralysis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes.
9.Patients with mental illness. 10.Patients with drug abuse/addiction. 11.Use of contraindicated medications.
1. . Steroids: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \>20 mg/day) within 7 days before leukocyte collection, or within 72 hours before CAR-T cell infusion targeting CD19 and CD22. However, physiological replacement, topical, and inhaled corticosteroids are allowed.
2. . Chemotherapy: Received salvage chemotherapy within 2 weeks before leukocyte collection.
3. . Allogeneic cell therapy: Received donor lymphocyte infusion within 4 weeks before leukocyte collection.
4. . GVHD treatment: Received anti-GVHD treatment within 4 weeks before CAR-T cell infusion targeting CD19 and CD22.
5. . Use of alemtuzumab, or cladribine within 6 months before leukocyte collection, or use of chlorambucil or clofarabine within 3 months.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：ORR · The overall response rate (ORR) includes both complete response (CR) and partial response (PR), and uses the Clopper-Pearson method to calculate the two-sided 95% confidence interval. · 3 years
患者先接受氟达拉滨联合环磷酰胺（F+C）淋巴细胞清除治疗，随后单次输注CAR1922T2 T细胞；输注后3年内按访视计划在规定时间点完成随访。
以上邮箱 / 电话是登记库里的申办方联系方式（中国内地座机），通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
本临床试验旨在评估CAR1922T2 T细胞治疗复发／难治性B细胞急性淋巴细胞白血病和非霍奇金淋巴瘤患者的安全性和疗效。受试者将接受一次CAR1922T2 T细胞输注，并在之后3年内完成随访。
The purpose of this clinical trial is to evaluate the safety and efficacy of CAR1922T2 T-cell therapy in participants with relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma. Participants will receive a single infusion of CAR1922T2 T-cells and complete follow-ups over the next three years.
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