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吞噬转移是否可预测CAR-T治疗弥漫性大B细胞淋巴瘤的反应?

英文原题:Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?

ClinicalTrials.gov 2024/04/08(首次登记) 注册临床试验(分期未标注) · 招募中

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于弥漫大 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 85 例。试验地点:欧洲 · 蒙彼利埃(共 2 个中心)。登记号:NCT06352242。

入组条件决定能不能参加

不限性别 · ≥ 18 Years · 接受健康志愿者

患者纳入标准:书面自愿知情同意参加非干预性CART-BANK方案,并口头同意参加CARTROG方案;入组时年龄>18岁;确诊大B细胞淋巴瘤(LDGCB);已决定接受抗CD19 CAR-T细胞治疗;参加社会保障体系或享有相应保障。

健康志愿者纳入标准:自愿口头同意参加CARTROG方案;入组时年龄18–70岁;无实体肿瘤或血液系统恶性肿瘤史;无已知慢性疾病(如高血压、糖尿病等)且未每日用药;过去6个月内未接受手术治疗。

排除标准:患者不符合全部纳入条件;妊娠或哺乳;因心理、家庭、社会或地理原因无法遵守研究流程和/或访视频率;无法自由同意参加,或处于监护、财产管理或司法保护状态。
核对登记原文(英文)
Inclusion Criteria:

* For patients

  * Patient who has given free and informed consent in writing for inclusion in the non-interventional CART-BANK protocol, and orally for the CARTROG protocol,
  * Patients over 18 years of age at the time of inclusion,
  * Diagnosis of LDGCB,
  * Decision to treat with anti-CD19 CAR-T cells,
  * Patient affiliated to or benefiting from a social security scheme.
* For healthy volunteers:

  * Given free and informed oral consent for inclusion in the CARTROG protocol,
  * Donor between 18 and 70 years of age at the time of inclusion,
  * No history of solid cancer or hematological malignancy,
  * No known chronic pathology (e.g. hypertension, diabetes, etc.) and no daily treatment,
  * No surgical treatment within the last 6 months.

Exclusion Criteria:

* Patients who do not meet all the inclusion criteria,
* Pregnant or breast-feeding patient,
* Patient unable to follow the procedures and/or frequency of visits planned in the trial, for psychological, family, social or geographical reasons,
* Patient unable to consent freely to inclusion, under guardianship, curatorship or safeguard of justice.

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

  • 主要终点识别可预测DLBCL患者未能达到完全代谢缓解的吞噬转移表型特征CAR-T细胞输注后6个月内。
  • 次要终点识别可预测≥II级免疫学不良事件的吞噬转移表型特征
  • 次要终点识别可预测严重血液学副作用发生的吞噬转移表型特征
  • 次要终点测定健康受试者正常淋巴细胞和NK细胞的吞噬转移水平
核对登记原文(英文)

主要终点:Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma. · Using flow cytometry to determine the level of trogocytosis, the phenotypic "signature" of trogocytosis will be assessed by the AUC : area under the ROC (Receiver operating characteristic) curve; established on circulating CAR-T cells, T lymphocytes and NK cells of patients, and defined as: the percentage of cells aberrantly expressing different tumor antigens normally expressed on lymphoma cells (CD19, CD20, etc.) at the different analysis times and/or the median florescence intensity (MFI) of the expression of these markers at the different analysis times and/or the evolution of these percentages and the MFI between 2 analysis times. Failure to obtain a complete metabolic response will be defined by: the absence of a complete metabolic response on the PET scans of D30, D90 and M6 in the absence of implementation of a new therapeutic line; or by the absence of complete metabolic response on all PET scans carried out before the implementation of a new therapeutic line. · During 6 months after CAR-T cells injection
次要终点:Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events;Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of serious hematological side effects.;Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects

研究设计怎么做的

研究类型
干预性研究
入组人数
85 人(预计)
分组方式
非随机分组
  • 患者其他

    采集血样进行流式细胞术分析。

  • 健康志愿者供者其他

    采集血样进行流式细胞术分析。

核对分组登记原文(英文)
  • Patients · OTHER · Blood sample for Flow cytometry analysis
  • healthy volunteer donor · OTHER · Blood sample for Flow cytometry analysis

关键日期

开始日期
2024-05-22
主要完成日期
2027-02-22
全部完成日期
2027-02-22
登记状态核实于
2026-06

联系与责任方

申办方
University Hospital, Montpellier
联系邮箱
v-rouille@chu-montpellier.fr
联系电话
+33467332645

登记简述

CAR-T细胞治疗改善了复发或难治性弥漫性大B细胞淋巴瘤(DLBCL R/R)患者的生存,但仅约65%的患者治疗后达到完全代谢缓解,目前尚无预测CAR-T输注后治疗反应的检测方法。近期研究显示,免疫细胞的吞噬转移水平与血液系统恶性肿瘤患者肿瘤细胞持续存在相关。本研究主要目标是识别一种吞噬转移表型特征,用于预测DLBCL患者CAR-T输注后6个月的治疗反应。

核对登记原文(英文)

CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL.

登记原文与核验信息

试验登记号
NCT06352242
试验期别
NA
试验状态
招募中
试验中心
Clinical hematology department, University Hospital · 蒙彼利埃 · 法国 | Clinical Investigation Center, University Hospital · 蒙彼利埃 · 法国
适应症(原文)
Diffuse Large B Cell Lymphoma
干预方式(原文)
Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients; Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers