肿瘤细胞治疗研究
英文原题：Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies
⚠ 该试验的登记信息已有 15 个月未更新， 页面上显示的「进行中（不再招募）」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 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、B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 28 例。试验地点：中国 · 武汉（共 1 个中心，其中中国 1 个）。登记号：NCT06220097。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
入选标准 1. 年龄≥18岁且<75岁。 2. ECOG体能状态≤2。 3. 临床诊断为复发/难治性B细胞恶性肿瘤。复发指初始化疗达到完全缓解（CR）后复发；难治定义为符合以下任一项：标准化疗后肿瘤缩小<50%或疾病进展（PD）；标准化疗达到CR后6个月内复发；达到CR后复发≥2次；造血干细胞移植后复发。B细胞恶性肿瘤包括：B细胞急性淋巴细胞白血病（B-ALL）；惰性B细胞淋巴瘤（CLL、FL、MZL）；侵袭性B细胞淋巴瘤（DLBCL、BL、MCL）。 4. 流式细胞术（FCM）或免疫组化显示肿瘤细胞CD19表达阳性。 5. 器官功能符合：EF>50%且心电图无明显异常；SpO2≥90%；肌酐（Cr）≤2.5×ULN；ALT、AST≤5×ULN，总胆红素（TBil）≤3×ULN。 6. 女性血妊娠试验阴性；受试者同意采取有效避孕措施直至末次随访。 7. 患者本人或其法定监护人自愿参加并签署知情同意书。 排除标准 1. 既往多柔比星或其他蒽环类药物累计剂量超过多柔比星当量360 mg/m²（其他蒽环类按多柔比星1 mg当量=表柔比星2 mg换算）。 2. 对任何研究药物或其成分过敏。 3. 合并其他未得到有效控制的疾病，包括但不限于持续或控制不佳的感染、有症状的充血性心衰、不稳定型心绞痛、心律失常、控制不佳的肺部疾病或精神障碍。 4. 研究者判断存在CNS受累，且接受桥接治疗及CD19 CAR-T治疗风险可能较高。 5. 过去5年内患有其他活动性恶性肿瘤。 6. 异基因造血干细胞移植后复发，且曾发生3至4级急性移植物抗宿主病（GVHD）。 7. 妊娠或哺乳。 8. 活动性自身免疫病，且需全身免疫抑制治疗。 9. 研究者认为会增加受试者风险或干扰试验结果的其他情况。
Inclusion Criteria: 1. Aged ≥ 18 years and \<75 years. 2. Eastern Cooperative Oncology Group score≤ 2. 3. Clinically diagnosed refractory or relapsed B-cell malignancies. Relapse refers to "relapse after a complete response (CR) from initial chemotherapy"; refractory refers to "diagnosis can be made if any of the following are met:(1) tumor shrinkage of \<50% or disease progression (PD) after standard chemotherapy; (2) CR is achieved by standard chemotherapy but relapses within six months, (3) 2 or more recurrences after CR, (4) recurrence after hematopoietic stem cell transplantation"; B-cell malignancies include the following 3 categories: (1) B-cell acute lymphoblastic leukemia (B-ALL); (2) indolent B-cell lymphoma (CLL, FL, MZL); (3) aggressive B-cell lymphoma (DLBCL, BL, MCL). 4. Flow cytometry (FCM) or immunohistochemistry showed positive CD19 expression in tumor cells; 5. Organ function needs to meet the following conditions: 1\) EF \>50%, and there is no obvious abnormality on ECG; 2) SpO2≥90%； 3) Cr≤2.5 ULN; 4) ALT and AST≤5 ULN, TBil≤3 ULN; 6. Negativity of blood pregnancy test for women, and participants use effective methods of contraception until the last follow-up. 7. The patient or his or her legal guardian voluntarily participates in and signs an informed consent form. Exclusion Criteria: 1. Prior treatment with doxorubicin or other anthracyclines with a total cumulative dose of doxorubicin \>360 mg/m2 (other anthracyclines convert 1 mg of doxorubicin to 2 mg epirubicin). 2. Hypersensitivity to any of the study drugs or their components. 3. Concomitant other diseases that are not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, poorly controlled pulmonary diseases, or psychiatric disorders. 4. Investigators judge patients with central nervous system involvement who may be at high risk of receiving bridging therapy and CD19 CAR-T cell treatment. 5. Participants with other active malignancies within five years. 6. Patients with relapse after allogeneic hematopoietic stem cell transplantation who have had grade 3\~4 acute graft-versus-host response (GVHD). 7. Patients who are pregnant or breast-feeding. 8. Active autoimmune disease requiring systemic immunosuppressive therapy. 9. Other conditions considered to increase the risk to the subject or interfere with the results of the trial by the researcher.
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：The overall response rate (ORR) of patients after bridging therapy · The overall response rate (ORR) was based on the Lugano 2014 Lymphoma Efficacy Evaluation Criteria (Cheson 2014) and the 2021 version of the ALL Efficacy Evaluation Index · After bridging therapy and before CD19 CAR-T infusion
次要终点：Complete response rate (CR) of patients after bridging therapy and CD19 CAR-T infusion；In vivo expansion and survival of CD19 CAR-T cells；Incidence of Treatment-related Adverse Events
入组后、CAR-T输注前28至7天内，所有受试者接受含盐酸米托蒽醌脂质体注射液的联合方案，包括但不限于R-MINE（盐酸米托蒽醌脂质体注射液、利妥昔单抗、美司钠、异环磷酰胺和依托泊苷）、G-MINE（盐酸米托蒽醌脂质体注射液、奥妥珠单抗、美司钠、异环磷酰胺和依托泊苷）及MAE方案（盐酸米托蒽醌脂质体注射液、阿糖胞苷和依托泊苷）。
这是一项开放标签、单臂、实用性II期临床研究，旨在评估含盐酸米托蒽醌脂质体注射液方案用于CD19 CAR-T桥接治疗的疗效和安全性。研究重点是评价该联合方案作为桥接治疗的效果。受试者将接受含盐酸米托蒽醌脂质体注射液的联合桥接方案及CAR-T细胞治疗，以评估其对桥接治疗疗效的影响。
The goal of this open, single-arm practical, phase II, clinical study is to evaluate the efficacy and safety of the mitoxantrone hydrochloride liposome injection-containing regimens in bridging therapies of CD19 CAR-T cells. The main question it aims to answer is: • the efficacy of the mitoxantrone hydrochloride liposome injection-containing combination regimens in bridging therapies of CD19 CAR-T cells. Participants will receive combination bridging regimens including mitoxantrone hydrochloride liposomal injection and CAR-T cell therapy to see if the combination regimens have a positive effect on the efficacy of bridging therapies.
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