肿瘤细胞治疗研究
英文原题：Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
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：NCT03271632。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准： • 男性或女性，患有经表面抗原确认的多发性骨髓瘤，且无可用的根治性治疗选择（包括自体或异基因造血干细胞移植）。 • 至少接受过4种既往联合治疗方案后仍未达到完全缓解（CR）。 • 多发性骨髓瘤处于CR2或CR3，且因年龄、合并症或缺乏合适供者而不适合异基因移植。 • 末次化疗至疾病进展间隔不足1年（即最近一次无进展间期<1年）。 • 既往自体或异基因移植后复发，至少接受过一种既往治疗后仍复发或有残留病灶，且不适合异基因移植。 • 一线治疗后仍有残留病灶且不适合自体移植（ASCT）。 • 预期生存期>12周。 • 肌酐<2.5 mg/dL。 • ALT/AST<正常值上限的3倍。 • 胆红素<2.0 mg/dL。 • 既往移植后任何复发均可入组，不受其他既往治疗情况限制。 • 静脉通路适合单采，且无其他白细胞分离禁忌证。 • 自愿签署知情同意书。 排除标准： • 妊娠或哺乳期女性。 • 未控制的活动性感染。 • 活动性乙型或丙型肝炎感染。 • 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。 • 既往接受过相关CAR-T细胞治疗；存在任何可能妨碍参加研究的未控制活动性疾病。 • HIV感染。
Inclusion Criteria: * Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT). * Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens. * MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor. * Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). * Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. * Residual disease after primary therapy and not eligible for ASCT * Expected survival \> 12 weeks * Creatinine \< 2.5 mg/dl * ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \< 3x normal * Bilirubin \< 2.0 mg/dl * Any relapse after prior SCT is eligible regardless of other prior therapy * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Voluntary informed consent is given Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation * HIV infection
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 effect · percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests. · 1 month
次要终点：Anti-tumor activity of fourth generation multiple CAR-T cells after infusion；Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM
CAR-T细胞治疗多发性骨髓瘤。
本临床试验旨在评估靶向多种癌细胞表面抗原的自体CAR-T细胞免疫疗法用于复发/难治性多发性骨髓瘤患者的可行性、安全性和疗效。研究还将进一步了解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 autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
MEMBER ACCOUNT
登录成功会直接打开下一页。
