肿瘤细胞治疗研究
英文原题：Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma
这是一项 II 期注册临床试验，评估细胞治疗用于套细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 37 例。试验地点：中国 · 天津（共 2 个中心，其中中国 2 个）。登记号：NCT07261163。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准：
1. 年龄18至80岁（含），男女均可。
2. 组织学或细胞学确诊为套细胞淋巴瘤（MCL），根据Lugano标准至少有一个可测量病灶。
3. 既往未接受过针对MCL的系统性治疗。
4. 美国东部肿瘤协作组（ECOG）体能状态评分为0至2。
5. 器官功能充分，定义如下：
1. 血液学功能（入组前14天内未接受红细胞或血小板输注、生长因子支持或药物纠正）：中性粒细胞绝对计数（ANC）≥ 1 × 10⁹/L；血小板计数（PLT）≥ 75 × 10⁹/L；
2. 生化检查必须符合以下标准：
总胆红素 ≤ 2.0 × 正常值上限（ULN）；丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）≤ 2.0 × ULN；肌酐清除率 ≥ 30 mL/min，按Cockcroft-Gault公式计算；
3. 心功能：超声心动图左心室射血分数（LVEF）≥ 50%。
6. 有生育能力的女性受试者必须在开始研究治疗前7天内血清妊娠试验阴性，并必须同意在研究期间及末次研究药物给药后6个月内采用高效避孕方法（如宫内节育器、激素避孕或使用避孕套）。伴侣有生育能力的男性受试者必须已行手术绝育或同意在研究期间及末次研究药物给药后6个月内采用有效避孕措施。
7. 愿意且能够提供书面知情同意，并遵守研究随访要求。
排除标准：
1. 已知中枢神经系统（CNS）受累，包括脑或脑膜淋巴瘤。
2. 纽约心脏协会（NYHA）III级或IV级心功能不全的充血性心力衰竭。
3. 过去3年内有其他原发恶性肿瘤病史，但非黑色素瘤皮肤癌、被认为已治愈的局限性前列腺癌、宫颈原位癌或PAP涂片检出的鳞状上皮内病变除外。
4. 既往接受过研究性药物治疗。
5. 首次给予研究药物前2周内需要抗微生物治疗的活动的全身性病毒、细菌或真菌感染。
6. 首次给予研究药物前7天内使用免疫抑制剂，但鼻内或吸入性皮质类固醇，或生理剂量的全身性皮质类固醇（即 ≤ 20 mg/天泼尼松或等效剂量）除外。
7. 超敏反应、过敏反应或药物不良反应史：对单克隆抗体的严重超敏反应；对输注过敏或不耐受；对研究药物或预处理药物有严重过敏史。
8. 体格或实验室检查发现：先天性或获得性免疫缺陷，如活动性乙型肝炎（HBV DNA ≥ 500 IU/mL）、丙型肝炎（HCV抗体阳性且HCV-RNA高于检测下限），或HBV和HCV合并感染；妊娠或哺乳期女性；有生育潜力但不愿或不能使用有效避孕措施的受试者；已知人类免疫缺陷病毒（HIV）检测阳性史或获得性免疫缺陷综合征（AIDS）病史。
9. 研究者判断可能影响受试者安全性或影响其遵守研究方案能力的任何情况。
10. 研究者认为不适合入组的其他情况。
Inclusion Criteria:
1. Age between 18 and 80 years inclusive, both genders are eligible.
2. Histologically or cytologically confirmed diagnosis of Mantle Cell Lymphoma (MCL), with at least one measurable lesion according to Lugano criteria.
3. No prior systemic therapy for MCL.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Adequate organ function, defined as:
1. Hematologic function (without red blood cell or platelet transfusion, growth factor support, or medication correction within 14 days prior to enrollment):Absolute neutrophil count (ANC) ≥ 1 × 10⁹/L;Platelet count (PLT) ≥ 75 × 10⁹/L;
2. Biochemical tests must meet the following criteria::
Total bilirubin ≤ 2.0 × upper limit of normal (ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN;Creatinine clearance ≥ 30 mL/min, calculated by the Cockcroft-Gault formula;
3. Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram.
6. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of study treatment, and must agree to use a highly effective method of contraception (e.g., intrauterine device, hormonal contraception, or condom use) during the study and for 6 months after the last dose of study drug. Male subjects whose partners are of childbearing potential must be surgically sterile or agree to use effective contraception during the study and for 6 months after the last dose of study drug.
7. Willing and able to provide written informed consent and comply with the study follow-up requirements.
Exclusion Criteria:
1. Known central nervous system (CNS) involvement, including brain or meningeal lymphoma.
2. Congestive heart failure with New York Heart Association (NYHA) Class III or IV cardiac dysfunction.
3. History of other primary malignancies within the past 3 years, except for non-melanoma skin cancer, localized prostate cancer considered cured, cervical in situ carcinoma, or squamous intraepithelial lesion detected by PAP smear.
4. Prior treatment with investigational drugs.
5. Active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to first administration of study drug.
6. Use of immunosuppressive agents within 7 days prior to first administration of study drug, except for intranasal or inhaled corticosteroids, or systemic corticosteroids at physiologic doses (i.e., ≤ 20 mg/day prednisone or equivalent).
7. History of hypersensitivity, allergic reactions, or adverse drug reactions:Severe hypersensitivity reaction to monoclonal antibodies;Allergy or intolerance to infusions;History of severe allergy to study drugs or premedication agents.
8. Physical or laboratory findings:Congenital or acquired immunodeficiency, such as active hepatitis B (HBV DNA ≥ 500 IU/mL), hepatitis C (positive HCV antibody and HCV-RNA above lower limit of detection), or co-infection with both HBV and HCV; Pregnant or breastfeeding women; subjects of childbearing potential unwilling or unable to use effective contraception; Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).
9. Any condition that, in the investigator's judgment, may impair subject safety or ability to comply with the study protocol.
10. Other conditions deemed unsuitable for enrollment by the investigator.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：complete response rate (CR) · To assess the complete response rate (CR) at the end of Induction therapy \[Time Frame: up to the end of induction treatment · up to the end of 6 cycles of treatment (each cycle is 28 days)
次要终点：Overall Response Rate (ORR)；Duration of Response (DoR)；Progression-free survival (PFS)；Overall survival；The safety
这是一项前瞻性、开放标签、单臂临床试验，评估一种针对初治套细胞淋巴瘤（MCL）的治疗策略。该研究将入组既往未接受过针对MCL的系统性治疗的患者。所有患者将接受ZGR诱导方案。将应用风险适应性维持治疗：非高危患者将分别接受来那度胺和泽布替尼维持治疗1年和2年；高危患者将接受CAR-T细胞治疗，随后接受相同的维持方案。主要目的是评估该治疗方法在MCL一线治疗中的可行性和初步疗效。
This is a prospective, open-label, single-arm clinical trial evaluating a treatment strategy for previously untreated Mantle Cell Lymphoma (MCL). The study will enroll patients who have not received prior systemic therapy for MCL. All patients will receive the ZGR induction regimen. Risk-adapted maintenance therapy will be applied: non-high-risk patients will receive lenalidomide and zanubrutinib maintenance for 1 and 2 years, respectively; high-risk patients will undergo CAR-T cell therapy followed by the same maintenance regimen. The primary objective is to assess the feasibility and preliminary efficacy of this treatment approach in the first-line setting of MCL.
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