更新于：2024-11-21

Dilanubicel

更新于：2024-11-21

概要

研发状态

概要

基本信息

药物类型

造血干细胞疗法

别名

Ex vivo expanded universal donor cellular therapies Nohla Therapeutics、Ex vivoexpanded cord blood progenitor cells、Haematopoetic progenitor cell therapy Nohla Therapeutics

+ [3]

靶点-

作用机制

细胞替代物

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病

在研适应症

急性双表型白血病急性白血病急性淋巴细胞白血病+ [4]

非在研适应症

急性红细胞白血病急性巨核细胞白血病急性放射综合征+ [5]

原研机构

Fred Hutchinson Cancer Research Center

在研机构

National Cancer Institute

Fred Hutchinson Cancer Research Center

Nohla Therapeutics, Inc.

+ [1]

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评快速通道 (美国)、孤儿药 (美国)

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关联

项与 Dilanubicel 相关的临床试验

NCT04083170 / Terminated临床2期IIT

Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells to Facilitate the Engraftment of a Single CCR5Δ32 Homozygous or Heterozygous Cord Blood Unit in Patients With HIV and Hematological Malignancies

This phase II trial studies the side effects of a cord blood transplant using dilanubicel and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. Dilanubicel consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with dilanubicel may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.

开始日期2022-10-06

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

NCT03399773 / Recruiting临床2期IIT

Pilot Study: Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Progenitor Cells (Dilanubicel) in the Setting of Single Cord Blood Transplantation for Patients With Hematologic Malignancies

This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

开始日期2022-05-10

申办/合作机构

Fred Hutchinson Cancer Research Center

[+3]

NCT03301597 / Terminated临床2期

A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects with AML.

开始日期2018-01-24

申办/合作机构

Nohla Therapeutics, Inc.

100 项与 Dilanubicel 相关的临床结果

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100 项与 Dilanubicel 相关的转化医学

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100 项与 Dilanubicel 相关的专利（医药）

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100 项与 Dilanubicel 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
急性双表型白血病	临床2期	美国	National Cancer Institute	2022-05-10
急性双表型白血病	临床2期	美国	Nohla Therapeutics, Inc.	2022-05-10
急性白血病	临床2期	美国	National Cancer Institute	2022-05-10
急性白血病	临床2期	美国	Nohla Therapeutics, Inc.	2022-05-10
急性白血病	临床2期	美国	Fred Hutchinson Cancer Research Center	2022-05-10
急性淋巴细胞白血病	临床2期	美国	Nohla Therapeutics, Inc.	2022-05-10
急性淋巴细胞白血病	临床2期	美国	Fred Hutchinson Cancer Research Center	2022-05-10
急性淋巴细胞白血病	临床2期	美国	National Cancer Institute	2022-05-10
急性髓性白血病	临床2期	美国	Deverra Therapeutics, Inc.初创企业	-
白细胞减少	临床前	美国	Nohla Therapeutics, Inc.	2018-01-21

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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


ASH2024	N/A	-	-	Dilanubicel	衊廠遞製醖醖餘構鹽夢(網夢齋網築鹹積鏇製網) = 憲糧壓鏇餘蓋淵築齋鏇顧簾鹽衊簾艱壓遞觸顧 (顧網簾膚醖鏇齋衊夢範 ) 更多	-	2024-12-07
NCT01690520 (CTgov)	临床2期	复发性急性髓细胞白血病 \| 急性淋巴细胞白血病 \| 费城染色体阳性慢性粒细胞白血病 \| 急性双表型白血病 \| 骨髓增生异常综合征	163	Umbilical Cord Blood Transplantation+Cyclosporine+Fludarabine Phosphate+Cyclophosphamide+mycophenolate mofetil+Thiotepa (Arm I (Standard of Care))	(襯醖繭繭遞醖積選顧獵) = 簾醖鹽壓觸膚構積艱齋鬱遞餘網願齋製鑰齋餘 (繭製餘製窪醖顧衊廠鏇, 窪蓋鑰艱選積夢衊範築 ~ 選憲製範衊窪獵構廠壓) 更多	-	2021-07-06
				Umbilical Cord Blood Transplantation+Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion+Cyclosporine+Fludarabine Phosphate+Cyclophosphamide+mycophenolate mofetil+Thiotepa (Arm II (Experimental))	(襯醖繭繭遞醖積選顧獵) = 範醖繭鏇構鹹鹽築觸窪鬱遞餘網願齋製鑰齋餘 (繭製餘製窪醖顧衊廠鏇, 艱夢蓋艱網糧觸積顧憲 ~ 鹹鬱鏇鑰憲壓遞衊廠鹹) 更多
NCT01690520 (GlobeNewswire) 人工标引	临床2期	血液肿瘤	16	Dilanubicel	艱膚選製糧遞選淵鬱鹽(膚壓鑰觸蓋憲艱鹽製淵) = 襯願網顧壓憲襯廠鹹簾遞製糧憲淵蓋鏇餘衊觸 (鏇簾鑰襯繭壓襯醖壓簾 ) 更多	积极	2018-06-15
				Standard of Care	艱膚選製糧遞選淵鬱鹽(膚壓鑰觸蓋憲艱鹽製淵) = 築願願築憲淵觸鹽築鏇遞製糧憲淵蓋鏇餘衊觸 (鏇簾鑰襯繭壓襯醖壓簾 ) 更多