肿瘤细胞治疗研究
英文原题：APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
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⚠ 该试验的登记信息已有 53 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。
这是一项早期 I 期注册临床试验，评估 CAR-T 细胞治疗多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 36 例。试验地点：中国 · 杭州（共 1 个中心，其中中国 1 个）。登记号：NCT04657861。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准：组织学确诊BCMA/TACI阳性多发性骨髓瘤，且符合以下情况之一：BCMA CAR-T 治疗后复发，或骨髓瘤BCMA/TACI表达阳性；造血干细胞移植后复发；微小残留病持续阳性复发；有难以通过化疗或放疗清除的髓外病灶；年龄18-75岁；总胆红素≤51 μmol/L，ALT和AST≤正常值上限3倍，肌酐≤176.8 μmol/L；超声心动图LVEF≥50%；无活动性肺部感染，室内空气下血氧饱和度≥92%；预期生存期≥3个月；ECOG 0-2分；患者或法定监护人自愿参加并签署知情同意书。排除标准：创伤性脑损伤、意识障碍、癫痫、脑血管缺血或出血性疾病史；心电图QT间期延长或既往严重心脏病（如严重心律失常）；妊娠或哺乳；严重活动性感染（单纯尿路感染和细菌性咽炎除外）；活动性乙肝或丙肝感染；筛查前2周内接受全身类固醇治疗（近期或目前使用吸入类固醇者除外）；既往接受任何CAR-T 产品或其他基因修饰T细胞治疗；肌酐>2.5 mg/dL、ALT/AST>正常值3倍或胆红素>2.0 mg/dL；其他不适合参加试验的未控制疾病；HIV感染；研究者认为可能增加患者风险或干扰研究结果的其他情况。
Inclusion Criteria: 1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM)： 1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression; 2. Relapsed after hematopoietic stem cell transplantation; 3. Cases with recurrent positive minimal residual disease; 4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. Male or female aged 18-75 years; 3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 6. Estimated survival time ≥ 3 months; 7. ECOG performance status 0 to 2; 8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
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：Dose-limiting toxicity (DLT) · Adverse events assessed according to NCI-CTCAE v5.0 criteria · Baseline up to 28 days after APRIL targeted CAR T-cells infusion；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Time Frame: Up to 2 years after APRIL targeted CAR T-cells infusion
次要终点：Multiple Myeloma (MM), Overall response rate (ORR)；MM, Overall survival (OS)；MM, Event-free survival (EFS)；Quality of life including sports activity；Activities of Daily Living (ADL) score；Instrumental Activities of Daily Living (IADL) score；Hospital Anxiety and Depression Scale (HADS) score
每名受试者通过静脉输注APRIL CAR-T 细胞。
以上邮箱 / 电话是登记库里的申办方联系方式（+86，中国），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。
研究APRIL CAR-T 细胞治疗BCMA/TACI阳性复发和/或难治性多发性骨髓瘤患者。
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
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