肿瘤细胞治疗研究
英文原题：Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)
⚠ 该试验的登记信息已有 42 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 CAR-T 细胞治疗霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 97 例。试验地点：美国 · 杜阿尔特、芝加哥、费城、纳什维尔（共 5 个中心）。登记号：NCT04268706。
不限性别 · ≥ 12 Years 且 ≤ 75 Years
纳入标准：资格在采血前判定。 1. 已签署知情同意书。 2. 男性或女性，年龄12–75岁。 3. 组织学确诊经典型霍奇金淋巴瘤（cHL）。 4. CD30阳性cHL复发/难治，且至少3线既往治疗失败，包括化疗、维布妥昔单抗（BV）和/或PD-1抑制剂。允许既往自体和/或异基因干细胞移植。 5. 肿瘤CD30阳性。 6. 按Lugano分类至少有1个可测量病灶。 7. 实验室指标：血红蛋白≥8.0 g/dL；总胆红素≤ULN的1.5倍；AST和ALT≤ULN的5倍；肌酐清除率>45 mL/min；ANC>1,000/μL；血小板>75,000/μL；PT或INR≤ULN的1.5倍，PTT或aPTT≤ULN的1.5倍。 8. ECOG体能状态0–1，或等同的Karnofsky评分（≥16岁）/Lansky评分（<16岁）。 9. 预期生存期>12周。 排除标准： 1. 有淋巴瘤累及中枢神经系统（CNS）的证据。 2. 有临床相关或活动性癫痫发作、卒中、脑血管缺血/出血、痴呆、小脑疾病，或累及CNS的自身免疫病。 3. 活动性未控制出血或已知出血倾向。 4. 肺功能不足：室内空气脉搏血氧饱和度<90%。 5. 超声心动图或MUGA显示LVEF<45%。 6. 正在接受免疫抑制药物或长期全身性皮质类固醇治疗。 7. 既往治疗时间不符合要求：CD30.CAR-T输注前4周内接受抗CD30抗体治疗；既往接受试验性CD30.CAR-T；输注前8周内使用CD30双特异性药物；输注前90天内接受自体HSCT或180天内接受异基因HSCT。 8. 入组前4周内正在接受任何试验药物，或输注前6周内接受任何肿瘤疫苗。 9. 活动性急性或慢性GVHD且需要免疫抑制治疗，不限级别。 10. 有HIV感染证据。 11. HBV或HCV血清阳性且有活动性感染证据。 12. 既往治疗相关非血液学毒性尚未恢复至≤1级。 13. 有对含鼠源蛋白产品或其他产品辅料发生超敏反应史。 14. 有症状的心血管疾病，NYHA心功能Ⅲ或Ⅳ级。 15. 活动性第二原发恶性肿瘤，或过去3年内有其他恶性肿瘤史。 16. 妊娠或计划妊娠、哺乳期，或有生育能力但未使用且不愿使用两种高效避孕方法。 17. 其他严重、危及生命或不稳定的既往疾病。
Inclusion Criteria: Eligibility is determined prior to blood collection . Patients must satisfy the following criteria to be enrolled in the study: 1. Signed Informed Consent Form 2. Male or female patients who are 12 - 75 years of age 3. Histologically confirmed classical Hodgkin Lymphoma 4. Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including: * chemotherapy * BV and/or * PD-1 inhibitor Patients may have previously received an autologous and/or allogeneic stem cell transplant 5. CD30-positive tumor 6. At least 1 measurable lesion according to The Lugano Classification 7. Laboratory parameters: Hematological, renal and hepatic functions, and coagulation parameters * Hgb ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 × ULN * AST and ALT ≤ 5 × the ULN * CrCl \> 45 mL/min * ANC \>1,000/µL * Platelets \>75,000/µL * PT or INR ≤ 1.5 × ULN; PTT or aPTT ≤ 1.5 × ULN 8. ECOG PS of 0 to 1 or equivalent \[either Karnofsky PS (for patients ≥ 16 year of age) or Lansky PS (for patients \< 16 years of age)\] 9. Anticipated life expectancy \> 12 weeks Exclusion Criteria: 1. Evidence of lymphomatous involvement of central nervous system (CNS) 2. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement 3. Active uncontrolled bleeding or a known bleeding diathesis 4. Inadequate pulmonary function defined as pulse oximetry \< 90% on room air 5. ECHO or MUGA with LVEF \< 45% 6. On-going treatment with immunosuppressive drugs or chronic systemic corticosteroids 7. Having received: * Anti-CD30 antibody-based therapy within 4 weeks prior to CD30.CAR-T infusion * Prior investigational CD30.CAR-T * CD30 bispecific agent within 8 weeks prior to CD30.CAR-T infusion * Autologous HSCT within 90 days or allogeneic HSCT within 180 days prior to CD30.CAR-T infusion 8. Currently receiving any investigational agents within 4 weeks prior to study enrollment; or received any tumor vaccines within 6 weeks prior to CD30.CAR-T infusion 9. Active acute or chronic graft versus host disease (GVHD) requiring immune suppression regardless of grade 10. Evidence of human immunodeficiency virus (HIV) infection 11. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 12. Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments 13. History of hypersensitivity reactions to murine protein-containing products or other product excipients 14. Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification 15. Active second malignancy or history of another malignancy within the last 3 years 16. Women who are pregnant or intending to become pregnant; women who are breastfeeding; persons with procreative potential not using and not willing to use 2 highly effective methods of contraception 17. Any other serious, life-threatening, or unstable preexisting medical conditions
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：Pilot: Safety of autologous CD30.CAR-T · Adverse events · Minimum 24 months post-CD30.CAR-T infusion；Pivotal: Anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014) · ORR · As early as 6 weeks after CD30.CAR-T treatment
次要终点：Pilot: Antitumor efficacy of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson et al., 2014)；Pilot: Duration of Response；Pilot: Progression Free Survival；Pilot: Overall Survival；Pilot: Health Related quality of life (HRQoL) questionnaire；Pivotal: Number of patients with adverse events as a measure of safety and tolerability of CD30.CART cells；Pivotal: Objective response rate (ORR as assessed by IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)；Pivotal: Progression Free Survival (PFS)
既往至少3线治疗失败（可包括自体和/或异基因干细胞移植）的复发/难治性经典型霍奇金淋巴瘤患者接受自体CD30.CAR-T细胞治疗。
这是一项分为两部分的Ⅱ期、多中心、开放标签、单臂研究，旨在评估自体CD30.CAR-T细胞治疗成人和儿童复发/难治性CD30阳性经典型霍奇金淋巴瘤患者的安全性和疗效。
This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.
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