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双靶点嵌合抗原受体T细胞治疗B细胞血液系统肿瘤的疗效观察

英文原题:To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors

ClinicalTrials.gov 2022/05/24(首次登记) I 期注册临床试验 · 招募中

⚠ 该试验的登记信息已有 16 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。

简要介绍

这是一项 I 期注册临床试验,评估自体 CAR-T 细胞治疗相关疾病的安全性、可行性及初步疗效。当前状态:招募中。计划入组 100 例。试验地点:中国 · 武汉(共 1 个中心,其中中国 1 个)。登记号:NCT05388695。

入组条件决定能不能参加

不限性别 · ≥ 18 Years 且 ≤ 70 Years

纳入标准:临床诊断复发/难治性B细胞肿瘤,包括B细胞急性淋巴细胞白血病、惰性B细胞淋巴瘤(CLL、FL、MZL)或侵袭性B细胞淋巴瘤(DLBCL、BL、MCL);免疫组化或流式细胞术检测CD19阳性,且CD20或CD22阳性;年龄18-70岁;预期生存期>3个月;ECOG评分0-2分;至少一个符合RECIST 1.1的可测量肿瘤病灶;重要器官功能符合要求:射血分数>50%且心电图无明显异常,SpO2≥92%,肌酐≤正常值上限1.5倍,ALT/AST≤5倍,总胆红素≤3倍;计划妊娠的受试者同意入组前及研究期后6个月采取避孕措施,如妊娠或怀疑妊娠须立即告知研究者;受试者或监护人理解并签署知情同意书。排除标准:合并未有效控制疾病,包括持续或控制不佳的感染、有症状的充血性心衰、不稳定型心绞痛、心律失常、控制不佳的肺病或精神疾病;存在其他恶性肿瘤;严重且无法有效控制的感染;HBsAg或HBcAb阳性且外周血HBV DNA高于检测限;HCV抗体阳性且外周血HCV RNA阳性;CMV DNA阳性或外周血EB病毒DNA阳性;已知HIV或梅毒血清学阳性;对生物制品(包括抗生素)有严重过敏史;异体造血干细胞移植后复发且有3-4级急性移植物抗宿主病(GvHD);妊娠或哺乳;需全身免疫抑制治疗的活动性自身免疫病;研究者认为可能增加受试者风险或干扰研究结果的其他情况。
核对登记原文(英文)
Inclusion Criteria:

1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);
2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;

4.Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.

Exclusion Criteria:

1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;
2. Presence of other malignant tumors;
3. There are severe infections that cannot be effectively controlled;
4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;
5. Known positive serology for human immunodeficiency virus (HIV) or syphilis;
6. A history of severe allergies to biological products (including antibiotics);
7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);
8. Female patients who are under pregnancy and/or lactation;
9. Active autoimmune disease requiring systemic immunosuppressive therapy;
10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.

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。

研究终点衡量什么算有效

  • 主要终点疗效:缓解率最多3个月。
核对登记原文(英文)

主要终点:Efficacy: Remission Rate · Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR) · Up to 3 months

研究设计怎么做的

研究类型
干预性研究
入组人数
100 人(预计)
分组方式
不适用(单臂)
  • 19+22 CAR-T及19+20 CAR-T实验性

    符合条件的患者将接受19+22 CAR-T和19+20 CAR-T治疗。

核对分组登记原文(英文)
  • 19+22 CART and 19+20 CART · EXPERIMENTAL · Eligible patients will be treated with 19+22 CAR-T and 19+20 CAR-T.

关键日期

开始日期
2022-04-08
主要完成日期
2027-03-30
全部完成日期
2027-05-30
登记状态核实于
2025-06

联系与责任方

申办方
Hebei Senlang Biotechnology Inc., Ltd.
合作方
Hebei Taihe Chunyu Biotechnology Co., Ltd
联系邮箱
jiawei@tjh.tjmu.edu.cn
联系电话
008602783665555

登记简述

观察双靶点嵌合抗原受体T细胞治疗复发/难治性B细胞血液系统肿瘤的长期疗效和安全性,随访至少2年。

核对登记原文(英文)

To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).

登记原文与核验信息

试验登记号
NCT05388695
试验期别
I 期
试验状态
招募中
中国试验中心(1 个)
Tongji Hospital · 武汉 · 中国
适应症(原文)
19 and 22+ B Cell Hematologic Tumors; 19 and 20+ B Cell Hematologic Tumors
干预方式(原文)
Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells