肿瘤细胞治疗研究
英文原题：A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
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⚠ 该试验的登记信息已有 26 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，评估细胞治疗用于肿瘤、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 81 例。试验地点：美国 · 亚特兰大（共 1 个中心）。登记号：NCT06271252。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： • 能够签署知情同意书。 • 筛选时年龄18～75岁（含）。 • 预期生存期>12周。 • 根据国际骨髓瘤工作组（IMWG）2016年标准诊断为多发性骨髓瘤（MM）。 • 符合以下至少一项： • IgG型MM：血清M蛋白>10 g/L；IgA、IgD、IgE或IgM型MM：血清M蛋白>5 g/L；或 • 尿M蛋白>200 mg/24小时；或 • 轻链型MM：血清游离轻链（sFLC）>100 mg/L且K/λ游离轻链比值异常；或 • 存在髓外病灶（短径>1 cm）。 • Ⅰ期（剂量递增）：至少接受过3线治疗，既往接受过BCMA抗原阳性靶向治疗，且对末线治疗难治。 • Ⅰ期（剂量扩展）和Ⅱ期：既往接受过BCMA靶向治疗，包括BCMA双特异性抗体（如特立妥单抗）、BCMA抗体偶联药物（如BLENREP）和BCMA CAR-T（如CARVYKTI）。 • 血液学、肾、肝、肺及心功能充足。 • 受试者及其伴侣愿意采取有效避孕措施，直至研究用药（IMP）输注后2年。 排除标准： • 妊娠或哺乳期。 • HIV血清学阳性，或活动性乙肝和／或丙肝感染。 • 已知存在活动性或既往中枢神经系统（CNS）受累。 • 有自身免疫性疾病史（如克罗恩病、类风湿关节炎、系统性红斑狼疮），且造成终末器官损害，或过去2年内需要全身使用免疫抑制剂或其他药物。 • 存在未控制的活动性感染。 • 筛选访视前8周内接受过自体造血干细胞移植（ASCT），或计划在研究期间接受ASCT。 • 接受过异基因干细胞治疗。 • 研究者认为会干扰IMP评估的任何情况。 • 筛选访视前1年内接受过苯达莫司汀治疗。
Inclusion Criteria: Capable of giving signed informed consent Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF). Expected survival period is \>12 weeks. Diagnosis of MM according to the IMWG criteria (2016 version). One of the following criteria must be met: If immunoglobulin (Ig)G type MM, then serum M protein \>10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein \>5 g/L Urine M protein level \>200 mg/24 hour If light chain type MM, then serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal. Extramedullary lesions (\>1 cm for diameter of the short axis). For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy. For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM) Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function. Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion. Exclusion Criteria: Pregnant or breastfeeding. Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection Known active or prior history of CNS involvement History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years Presence of uncontrolled active infection Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study. Subjects who received allogeneic stem cell therapy. Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP. Received Bendamustine treatment 1 year prior to Screening Visit.
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：Maximum tolerated dose (MTD) of OriCAR-017 US-P1 · The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level. · Up to 28 days；Dose-limiting toxicity (DLT) · A DLT is defined as any of the treatment-emergent adverse events (TEAEs; a TEAE is defined as an adverse event \[AE\] that starts on or after the first administration of study medication) condition or concomitant medications. · Up to 28 days
次要终点：Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM；Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM；Assessment of Duration of Response (DOR) of treatment in patients with RR/MM；Progress-Free Survival (PFS) of treatment in patients with RR/MM；Assessment of Overall Survival (OS) of treatment in patients with RR/MM；Assessment of MRD negative Rate；Assessment of Overall Response Rate (ORR)；Assessment of Disease Control Rate (DCR)
单次输注OriCAR-017。
这是Oricell Therapeutics Inc.在美国开展的首项临床研究，旨在评估抗GPRC5D细胞产品OriCAR-017用于复发／难治性多发性骨髓瘤（RR/MM）受试者的安全性、药代动力学（PK）、药效学（PD）和初步疗效。 RIGEL研究。
The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study
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