肿瘤细胞治疗研究
英文原题：An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders
⚠ 该试验的登记信息已有 22 个月未更新， 页面上显示的「尚未开始招募」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。
这是一项分期未标注的注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤、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：尚未开始招募。计划入组 60 例。试验地点：其他 · 莫斯科（共 1 个中心）。登记号：NCT06721598。
不限性别 · ≥ 18 Years 且 ≤ 71 Years
纳入标准：已成功完成HemC101-01-01研究程序；有生育可能女性妊娠试验阴性。排除标准：未控制的危及生命感染（尿路感染可接受）；在研究用药前接受静脉抗生素，或入组前7天内未停止静脉抗生素者（允许预防性使用抗生素、抗病毒药或抗真菌药）；使用方案禁止的治疗措施（糖皮质激素、异体细胞治疗、GVHD治疗、化疗、阿仑单抗、氯法拉滨、克拉屈滨及鼠源生物制剂）；研究者认为未遵循HemC101-01-01程序可能使患者参加本研究存在风险并显著影响结果评估；研究者认为影响入组能力或增加患者风险的其他临床相关情况。
Inclusion Criteria: 1. Successful completion of the HemC101-01-01 study procedures. 2. Negative pregnancy test for women of reproductive potential. Exclusion Criteria: 1. Uncontrolled life-threatening infection. A urinary tract infection is acceptable. Patients who received intravenous antibiotics before IMP administration or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study. Prophylactic use of antibiotics, antiviral, or antifungal drugs is allowed. 2. The use of therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GVHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, and biologics derived from mouse materials). 3. Non-adherence to HemC101-01-01 study procedures that, in the investigator's opinion, put the patient at risk if they participate in the study and may significantly bias the assessment of study results. 4. Any clinically relevant data that, in the investigator's opinion, affects the patient's ability to enter the study and puts the patient at risk.
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：1. Incidence of Treatment-Emergent Adverse Events [Safety] · Frequency of any adverse events (AEs) reported during the study period and AE characterization (severity, seriousness, etc.) · 11 month starting on the 29th day after IMP administration；ORR [Efficacy] · Overall response rate (ORR) defined as the proportion of subjects with complete response (CR) or partial response (PR) · 11 month starting on the 29th day after IMP administration
在Hem101-01-01研究中接受Hem101治疗的受试者将继续随访11个月。
本随访研究旨在评估抗CD19 CAR-T细胞疗法治疗某些B细胞血液肿瘤成人患者的长期安全性和有效性，包括治疗后复发或对其他治疗无应答的疾病。该疗法使用患者自身免疫细胞，经实验室改造后特异性识别并清除表达CD19标志物的癌细胞。研究将观察患者长期耐受情况，以及治疗维持缓解或减轻疾病严重程度的能力。既往在其他临床试验接受过CAR-T治疗且符合特定标准的患者可参加。本研究约随访11个月，定期访视以监测副作用、评估肿瘤反应并追踪体内CAR-T细胞活性；不提供额外治疗，重点了解CAR-T治疗的长期结局。
This follow-up study is designed to evaluate the long-term safety and effectiveness of a treatment called anti-CD19 CAR-T cell therapy in adults with certain B-cell blood cancers. These cancers include types that have returned after treatment or have not responded to other therapies. CAR-T cell therapy involves using a patient's own immune cells, which are modified in a lab to specifically target and destroy cancer cells with a marker called CD19. The study will look at how well patients tolerate this treatment over time, as well as its ability to keep cancer in remission or reduce its severity. Patients who have previously received CAR-T therapy in an earlier clinical trial and meet specific criteria can participate in this study. The research will include regular follow-up visits over approximately 11 months to monitor for side effects, assess cancer response, and track the activity of CAR-T cells in the body. This study does not involve additional treatments but focuses on understanding the long-term outcomes of CAR-T therapy to provide better care for patients in the future.
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