肿瘤细胞治疗研究
英文原题：A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
⚠ 该试验的登记信息已有 15 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 I 期注册临床试验，评估异体NK 细胞治疗弥漫大 B 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 10 例。试验地点：欧洲 · 蒙彼利埃（共 1 个中心）。登记号：NCT07044050。
不限性别 · ≥ 18 Years
纳入标准： * 年龄≥18岁 * 组织学确诊为R/R DLBCL-NOS，且无进一步标准治疗方案，包括CAR T细胞治疗后复发或不适合CAR T细胞治疗者 * 具有可评估病灶 * 基线时具有足够的生物学参数 * ECOG体能状态≤1 * 研究者评估的预期寿命>3个月 排除标准： * 同时接受任何抗肿瘤导向药物治疗 * 治疗前或治疗期间接种任何活病毒疫苗 * 具有严重特应性体质，需要单克隆抗体、过敏原免疫治疗或长期全身性皮质类固醇治疗 * 3周内接受过大手术 * 疾病快速进展，包括大量未控制的胸腔、心包或腹腔积液、肺淋巴管炎，以及肝脏受累超过50% * 既往治疗未缓解的持续免疫相关毒性或不良事件等级>1，但白癜风、稳定至2级的神经病变、脱发以及通过替代激素治疗稳定的内分泌疾病除外 * 有记录的活动性自身免疫性疾病病史，且在过去12个月内需要全身性免疫抑制治疗 * 原发性或继发性免疫缺陷 * 需要静脉抗生素或抗病毒治疗的活动性未控制感染 * HIV、HBV或HCV血清学阳性（疫苗接种后或确诊治愈的肝炎除外） * 临床显著的心脏疾病，包括心力衰竭、未控制的高血压、既存心律失常、未控制的心绞痛，或12个月内的心肌梗死 * 痴呆或精神状态改变，无法签署知情同意 * 过去3年内的其他恶性肿瘤，但充分治疗的非黑色素瘤皮肤癌、宫颈原位癌或骨髓增生异常综合征除外
Inclusion Criteria: * ≥18 years of age * histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy * with evaluable disease * with adequate biological parameters at baseline * ECOG performance status ≤1 * life expectancy \>3 months as assessed by the investigator Exclusion Criteria: * Receive concomitantly any antitumor-directed drug therapy * Any vaccination with live virus vaccines before or during treatment * With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids * Major surgery within 3 weeks * With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement * Ongoing immune-related tocivities or adverse events grade \>1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy * Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months * Primary or secondary immune deficiency * Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment * Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV * Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months * Dementia or altered mental status that would prohibit informed consent * Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes
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：Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations. · All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose).
次要终点：Antitumor activity characterized by objective response rate per Lugano criteria.
OT-C001 1瓶，每周给药
OT-C001 3瓶，每周给药
OT-C001 1/3瓶（100M）
本临床试验的目的是了解OT-C001的安全性，并确定治疗复发或难治性弥漫性大B细胞淋巴瘤患者的良好剂量。同时还将了解OT-C001的初步活性。 参与者将： 在OT-C001治疗前接受短期化疗。在研究治疗期间，参与者将接受每周一次OT-C001给药，持续3或6周。在研究期间，参与者还将接受另外两种药物，利妥昔单抗和IL-2，以支持OT-C001治疗。 参与者需要按照研究计划前往诊所就诊或可能住院。
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001. Participants will: Receive a short course of chemotherapy before OT-C001 treatment. During the study treatment, participants will recieve weekly dose of OT-C001 for 3 or 6 weeks. During the study period, participants will also receive another two drugs, rituximab and IL-2, to support OT-C001 treatment. Participants need to visit the clinic or may be hospitalized according to the study plan.
MEMBER ACCOUNT
登录成功会直接打开下一页。
