HX-t001(HX-t001) - 在研适应症：巨细胞病毒血症_专利_临床

概要

基本信息

药物类型

TCR细胞疗法

别名

CMV (T cell Receptor) T cell therapy China Immunotech、CMV TCR T cell therapy (China Immunotech)、YTT 101

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靶点-

作用机制

基因转移、T淋巴细胞替代物

治疗领域

感染其他疾病

在研适应症

巨细胞病毒血症

非在研适应症-

原研机构

华夏英泰（北京）生物技术有限公司初创企业

在研机构

华夏英泰（北京）生物技术有限公司初创企业

非在研机构-

最高研发阶段临床前

首次获批日期-

最高研发阶段(中国)临床前

特殊审评-

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关联

3

项与 HX-t001 相关的临床试验

NCT05140187 / Recruiting临床1期IIT

Adoptive Immunotherapy With Donor-derived CMV-TCR-T Cells for Patients With CMV Infection After Allogenic HSCT

This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after allogenic HSCT.

开始日期2021-10-15

申办/合作机构

中国人民解放军总医院

NCT05089838 / Unknown status临床1期IIT

A Study of CMV-TCR-T Cells in the Treatment of Refractory CMV Viremia After HSCT

This is a single centre, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating refractory CMV infection after HSCT.

开始日期2021-01-06

申办/合作机构

北京大学人民医院

NCT04153279 / Completed临床1期IIT

A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT

This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.

开始日期2019-12-19

申办/合作机构

河北燕达陆道培医院

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100 项与 HX-t001 相关的临床结果

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100 项与 HX-t001 相关的转化医学

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100 项与 HX-t001 相关的专利（医药）

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2

项与 HX-t001 相关的文献（医药）

2024-01-01·Journal for immunotherapy of cancer

Adoptive transfer of CMV-specific TCR-T cells for the treatment of CMV infection after haploidentical hematopoietic stem cell transplantation

Article

作者: Liu, Dai-Hong ; Lu, Ning ; Ma, Chao ; Wang, Lu ; Wang, Yu ; Du, Jishan ; Chen, Peng ; Sun, Jiaojun ; Dou, Liping ; Qilong, Xu

Background:

Cytomegalovirus (CMV) reactivation after unmanipulated haploidentical stem cell transplantation (SCT) frequently occurs, causing life-threatening morbidities and transplantation failure. Pre-emptive therapy upon the detection of CMV viremia using antiviral agents is currently the standard of care but it was associated with significant toxicity. The CMV antigen-specific cytotoxic T lymphocyte therapy was limited by the time-consuming manufacture process and relatively low success rate. More effective and safer approaches for the treatment of CMV reactivation after haploidentical SCT are in urgent need.

Methods:

A single-arm, open-label, phase I clinical trial evaluating the safety and efficacy of CMV-targeting T cell receptor-engineered T (CMV-TCR-T) cell therapy as the first-line pre-emptive therapy for patients with CMV reactivation after haploidentical peripheral blood SCT (PBSCT) was conducted in the Chinese PLA General Hospital. Six patients with CMV reactivation after haploidentical SCT were adoptively transferred by one to three doses of SCT donors-derived CMV-TCR-T cells. This trial was a dose-escalation study with doses ranging from 1×103CMV-TCR-T cells/kg body weight per dose to 5×105CMV-TCR-T cells/kg per dose.

Results:

Except for the grade 1 cytokine release syndrome observed in one patient and mild fever in two patients, no other adverse events were observed. Four patients had response within a month after CMV-TCR-T cell infusion without the administration of any antiviral agents. The other two patients who initially did not respond to CMV-TCR-T cell therapy had salvage ganciclovir and foscarnet administration and then had rapid CMV clearance. The CMV-TCR-T cells displayed overall robust expansion and persistence in the peripheral blood after infusion. The CMV-TCR-T cells were first detected in the peripheral blood of these patients 3–7 days after the first dose of CMV-TCR-T infusion, rapidly expanded and persisted for at least 1–4 months, providing long-term protection against CMV reactivation. In one patient, the CMV-TCR-T cells started to expand even when the anti-graft-versus-host disease reagents were still being used, further indicating the proliferation potential of CMV-TCR-T cells.

Conclusions:

Our study first showed CMV-TCR-T cell as a highly feasible, safe and effective first-line pre-emptive treatment for CMV reactivation after haploidentical PBSCT.

Trial registration number:

ClinicalTrials.gov Registry (NCT05140187).

NPJ vaccines

Highly stable and immunogenic CMV T cell vaccine candidate developed using a synthetic MVA platform

Article

作者: Park, Yoonsuh ; Diamond, Don J ; Kaltcheva, Teodora ; Chiuppesi, Flavia ; Martinez, Joy ; Medrano, Leonard ; Kim, Taehyun ; Dempsey, Shannon ; Yll-Pico, Marcal ; Nguyen, Vu H ; Iniguez, Angelina ; Kha, Mindy ; Wussow, Felix

Abstract:

Human cytomegalovirus (CMV) is the most common infectious cause of complications post-transplantation, while a CMV vaccine for transplant recipients has yet to be licensed. Triplex, a multiantigen Modified Vaccinia Ankara (MVA)-vectored CMV vaccine candidate based on the immunodominant antigens phosphoprotein 65 (pp65) and immediate-early 1 and 2 (IE1/2), is in an advanced stage of clinical development. However, its limited genetic and expression stability restricts its potential for large-scale production. Using a recently developed fully synthetic MVA (sMVA) platform, we developed a new generation Triplex vaccine candidate, T10-F10, with different sequence modifications for enhanced vaccine stability. T10-F10 demonstrated genetic and expression stability during extensive virus passaging. In addition, we show that T10-F10 confers comparable immunogenicity to the original Triplex vaccine to elicit antigen-specific T cell responses in HLA-transgenic mice. These results demonstrate improvements in translational vaccine properties of an sMVA-based CMV vaccine candidate designed as a therapeutic treatment for transplant recipients.

100 项与 HX-t001 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
巨细胞病毒感染	临床1期	中国	华夏英泰（北京）生物技术有限公司初创企业	2019-12-19
巨细胞病毒血症	临床前	中国	华夏英泰（北京）生物技术有限公司初创企业	2022-01-30

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04153279 (Pubmed) 人工标引	临床1期	巨细胞病毒感染	7	pp65-specific TCR-T cell therapy	遞鹹網膚襯鏇鏇網獵壓(艱製鹽淵餘構壓簾鹽鹽) = 製鹽鏇鑰夢築鹹範遞鑰獵鬱積糧襯選選廠觸鹽 (鹽鏇襯積糧遞廠願淵衊 ) 更多	积极	2022-08-28