肿瘤细胞治疗研究
英文原题：Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
这是一项 I/II 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：尚未开始招募。计划入组 20 例。试验地点：中国 · 深圳（共 1 个中心，其中中国 1 个）。登记号：NCT06429150。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准： • 男性或女性多发性骨髓瘤或浆细胞瘤患者。 • 治疗目标为严格完全缓解（sCR）。 • 预期生存期超过12周。 • 既往接受过自体造血干细胞移植（auto-SCT）者，无论是否接受过其他既往治疗，均可入组。 • 静脉通路适合单采，且无其他白细胞分离禁忌证。 • 自愿签署知情同意，并承诺继续接受随访。 排除标准： • 妊娠或哺乳期女性。 • 未控制的活动性感染。 • 活动性HIV、乙型肝炎或丙型肝炎感染。 • 同时使用全身性类固醇；近期或当前使用吸入性类固醇不构成排除条件。 • 任何可能妨碍参加研究的疾病。
Inclusion Criteria: * Male and female subjects with multiple myeloma or plasmacytoma * Strictly complete remission (sCR) is a treatment goal * Expected survival \> 12 weeks * After prior auto-SCT is eligible regardless of other prior therapies * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given and commitment to continued follow-up Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * Active HIV, hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Any medical conditions that may preclude participation
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：Percentage of patients with treatment related adverse effects · The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0 · 1 month
次要终点：Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion；Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma
本临床试验旨在评估靶向多种癌细胞抗原的CAR-T细胞疗法，作为高危多发性骨髓瘤或浆细胞瘤患者一线治疗方案的可行性、安全性和疗效。研究还将进一步了解这些CAR-T细胞在体内的持续性和功能。
The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.
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