肿瘤细胞治疗研究
英文原题：Study on the Effect of Oral Diammonium Glycyrrhizinate in Attenuating Toxicity and Enhancing Efficacy of CAR-T Cell Therapy
这是一项 II/III 期注册临床试验，评估细胞治疗用于大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 21 例。登记号：NCT07616271。
不限性别 · ≥ 18 Years
纳入标准： 1. 年龄≥18岁。 2. 确诊大B细胞淋巴瘤并接受CAR-T细胞治疗。 3. 入组前器官功能充分：ALT和AST≤ULN的2.5倍；肝脏受累者可放宽至≤ULN的5倍；血清总胆红素<34 μmol/L；肌酐清除率>30 mL/min；心脏射血分数（EF）≥40%，且无心包积液或显著心律失常；室内空气下SpO₂≥92%。 4. 入组前MRI确认无淋巴瘤中枢神经系统受累。 5. 有生育可能的受试者同意采用高效避孕方法。 6. 受试者或其法定监护人能够理解并自愿签署书面知情同意。 排除标准： 1. 除本研究疾病外，既往患有需要持续全身治疗的其他恶性肿瘤。 2. 存在任何危及生命的疾病、医疗状况或器官系统功能障碍，研究者认为可能危及患者安全或干扰安全性/疗效数据解释。 3. 当前或既往恶性肿瘤累及中枢神经系统。 4. 入组前6个月内接受异基因造血干细胞移植，或入组前3个月内接受自体造血干细胞移植；患者不得有移植物抗宿主病体征或症状，且不得接受免疫抑制治疗。 5. 对甘草酸制剂不耐受或过敏。 6. 患者拒绝遵守研究要求以完成研究工作。 7. 研究者判断患者因行政或其他原因无法完成研究/遵守要求，或有其他不适合参加临床试验的原因。
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients diagnosed with large B-cell lymphoma and receiving CAR-T cell therapy. 3. Adequate organ function prior to enrollment: ALT and AST ≤ 2.5 × ULN (upper limit of normal); may be extended to ≤5 × ULN in patients with liver involvement; serum total bilirubin \< 34 μmol/L; creatinine clearance \> 30 mL/min; cardiac ejection fraction (EF) ≥ 40%, with no pericardial effusion or significant arrhythmia; room air SpO₂ ≥ 92%. 4. No central nervous system involvement of lymphoma confirmed by MRI prior to enrollment. 5. Subjects of childbearing potential must agree to use highly effective contraceptive methods. 6. The subject or their legal guardian must be able to understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Presence of a prior malignancy (other than the disease under study) that requires ongoing systemic treatment for any other malignant tumor. 2. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's judgment, may compromise patient safety or interfere with the interpretation of safety or efficacy data. 3. Current or prior central nervous system (CNS) involvement by malignancy. 4. Receipt of allogeneic stem cell transplantation within 6 months prior to enrollment, or autologous stem cell transplantation within 3 months prior to enrollment; and the patient must have no signs or symptoms of graft-versus-host disease and must not be receiving immunosuppressive therapy. 5. Intolerance or allergy to glycyrrhizic acid preparations. 6. Patient refuses to comply with the study requirements to complete the research work. 7. In the investigator's judgment, the patient is unable to complete the study or comply with the study requirements (due to administrative reasons or other reasons), or is considered unsuitable for clinical trial participation for other reasons.
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：CRS · CRS incidence and incidence of grade ≥3 CRS · Within 28 days post CAR-T cell infusion
次要终点：Complete remission rate；Objective Response Rate；Duration of response；Overall survival；Progression-free survival；Level of CAR-T cell persistence；Adverse events
CAR-T细胞输注时，在标准临床治疗基础上口服甘草酸二铵（前2周每日3次、每次150 mg；此后每日一次、每次100 mg），并持续口服2年。
CAR-T细胞输注后接受标准临床治疗，不额外使用甘草酸二铵。
本研究旨在评估口服甘草酸二铵能否降低大B细胞淋巴瘤患者CAR-T细胞治疗的毒性并增强疗效。研究关注两个主要问题：1）口服甘草酸二铵能否降低CAR-T细胞诱导的细胞因子释放综合征（CRS）发生率和严重程度；2）口服甘草酸二铵能否与CAR-T细胞治疗产生协同作用并提高疗效。
The purpose of this study is to evaluate the effect of oral diammonium glycyrrhizinate in reducing toxicity and enhancing efficacy of CAR-T cell therapy in patients with large B-cell lymphoma. Two main questions are addressed: 1) Can oral diammonium glycyrrhizinate reduce the incidence and severity of CRS induced by CAR-T cells? 2) Can oral diammonium glycyrrhizinate synergistically increase the therapeutic efficacy of CAR-T cell therapy?
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