ADCV-01(ADCV-01) - 在研适应症：多形性胶质母细胞瘤_专利_临床

概要

基本信息

药物类型

治疗性疫苗、树突状细胞疫苗

别名

Autologous dendritic cell vaccine、ADCV 01、ADCV01

靶点-

作用机制

免疫刺激剂、T淋巴细胞刺激剂

治疗领域

肿瘤神经系统疾病其他疾病

在研适应症

多形性胶质母细胞瘤

非在研适应症-

原研机构

长圣国际生技股份有限公司

在研机构

长圣国际生技股份有限公司

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-

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关联

2

项与 ADCV-01 相关的临床试验

NCT04115761 / Recruiting临床2期

A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients

This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme

开始日期2019-06-06

申办/合作机构

长圣国际生技股份有限公司

ISRCTN45563569 / CompletedN/AIIT

Mature Autologous Dendritic Cell Vaccines in Advanced Non-Small Cell Lung Cancer

开始日期2005-10-01

申办/合作机构-

100 项与 ADCV-01 相关的临床结果

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100 项与 ADCV-01 相关的转化医学

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100 项与 ADCV-01 相关的专利（医药）

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50

项与 ADCV-01 相关的文献（医药）

2024-04-01·BULLETIN OF EXPERIMENTAL BIOLOGY AND MEDICINE

Development of a Protocol for Obtaining a Homologous Cell Product of Animal Origin Intended for Preclinical Studies of Antitumor Vaccine CaTeVac

Article

作者: Grigoryevskaya, A V ; Laskov, I D ; Emelyanova, N V ; Baldueva, I A ; Efremova, N A ; Fedoros, E I ; Danilova, A B ; Nekhaeva, T L ; Blokhina, M L

When developing a program of preclinical studies of human cell-based drugs intended for adoptive immunotherapy of cancer patients, the biological effect should be substantiated by data describing their immunological action. Administration and study of human autologous dendritic cell vaccine to immunocompetent animals are not adequate in terms of immunological compatibility. It is possible to use immunocompromised, knockout, or transgenic animals or to obtain a homologous cellular product, namely, a preparation based on animal cells using a technology similar to obtaining the original preparation for clinical practice in humans. Within the framework of this study, we have developed a protocol for obtaining a homologous cell product based on animal dendritic cells (mice, rats) according to a similar technology for obtaining human vaccine dendritic cells, and demonstrated the comparability of morphological characteristics and expression of differentiation antigens of dendritic cells (CD11c, CD80, CD86, and CD83) of animals (mice) and humans.

2023-04-01·Cancer immunology, immunotherapy : CII

A Phase I-II multicenter trial with Avelumab plus autologous dendritic cell vaccine in pre-treated mismatch repair-proficient (MSS) metastatic colorectal cancer patients; GEMCAD 1602 study

Article

作者: Thomson, Timothy ; Benítez-Ribas, Daniel ; Cid, Joan ; Foguet, Carles ; Ginés, Angels ; García-Criado, Angeles ; Torres, Ferràn ; Cabezón, Raquel ; Pagés, Mario ; Fernández-Martos, Carlos ; Cuatrecasas, Miriam ; Rodríguez, Nuria ; Oliveres, Helena ; Lozano, Miquel ; Pineda, Estela ; Cascante, Marta ; Maurel, Joan ; Ruiz-Casado, Ana ; Ayuso, Juan Ramon ; Elez, Elena ; Pedrosa, Leire ; Español-Rego, Marta

Abstract:

Background:

Immune check-point blockade (ICB) has shown clinical benefit in mismatch repair-deficient/microsatellite instability high metastatic colorectal cancer (mCRC) but not in mismatch repair-proficient/microsatellite stable patients. Cancer vaccines with autologous dendritic cells (ADC) could be a complementary therapeutic approach to ICB as this combination has the potential to achieve synergistic effects.

Methods:

This was a Phase I/II multicentric study with translational sub-studies, to evaluate the safety, pharmacodynamics and anti-tumor effects of Avelumab plus ADC vaccine in heavily pre-treated MSS mCRC patients. Primary objective was to determine the maximum tolerated dose and the efficacy of the combination. The primary end-point was 40% progression-free survival at 6 months with a 2 Simon Stage.

Results:

A total of 28 patients were screened and 19 pts were included. Combined therapy was safe and well tolerated. An interim analysis (Simon design first-stage) recommended early termination because only 2/19 (11%) patients were disease free at 6 months. Median PFS was 3.1 months [2.1–5.3 months] and overall survival was 12.2 months [3.2–23.2 months]. Stimulation of immune system was observed in vitro but not clinically. The evaluation of basal RNA-seq noted significant changes between pre and post-therapy liver biopsies related to lipid metabolism and transport, inflammation and oxidative stress pathways.

Conclusions:

The combination of Avelumab plus ADC vaccine is safe and well tolerated but exhibited modest clinical activity. Our study describes, for the first-time, a de novo post-therapy metabolic rewiring, that could represent novel immunotherapy-induced tumor vulnerabilities.

2022-07-15·Clinical cancer research : an official journal of the American Association for Cancer Research

An Autologous Dendritic Cell Vaccine Promotes Anticancer Immunity in Patients with Ovarian Cancer with Low Mutational Burden and Cold Tumors

Article

作者: Fucikova, Jitka ; Cibula, David ; Hensler, Michal ; Halaska, Michael J. ; Laco, Jan ; Coosemans, An ; Kasikova, Lenka ; Praznovec, Ivan ; Hrnciarova, Tereza ; Galluzzi, Lorenzo ; Rakova, Jana ; Sojka, Ludek ; Brtnicky, Tomas ; Bartunkova, Jirina ; Hraska, Marek ; Dundr, Pavel ; Rob, Lukas ; Drozenova, Jana ; Fredriksen, Tessa ; Galon, Jérôme ; Rozkova, Daniela ; Vergote, Ignace ; Lanickova, Tereza ; Ryska, Ales ; Sochorova, Klara ; Spisek, Radek ; Pasulka, Josef

Abstract:

Purpose::

The successful implementation of immune checkpoint inhibitors (ICI) in the clinical management of various solid tumors has raised considerable expectations for patients with epithelial ovarian carcinoma (EOC). However, EOC is poorly responsive to ICIs due to immunologic features including limited tumor mutational burden (TMB) and poor lymphocytic infiltration. An autologous dendritic cell (DC)-based vaccine (DCVAC) has recently been shown to be safe and to significantly improve progression-free survival (PFS) in a randomized phase II clinical trial enrolling patients with EOC (SOV01, NCT02107937).

Patients and Methods::

We harnessed sequencing, flow cytometry, multispectral immunofluorescence microscopy, and IHC to analyze (pretreatment) tumor and (pretreatment and posttreatment) peripheral blood samples from 82 patients enrolled in SOV01, with the aim of identifying immunologic biomarkers that would improve the clinical management of patients with EOC treated with DCVAC.

Results::

Although higher-than-median TMB and abundant CD8+ T-cell infiltration were associated with superior clinical benefits in patients with EOC receiving standard-of-care chemotherapy, the same did not hold true in women receiving DCVAC. Conversely, superior clinical responses to DCVAC were observed in patients with lower-than-median TMB and scarce CD8+ T-cell infiltration. Such responses were accompanied by signs of improved effector functions and tumor-specific cytotoxicity in the peripheral blood.

Conclusions::

Our findings suggest that while patients with highly infiltrated, “hot” EOCs benefit from chemotherapy, women with “cold” EOCs may instead require DC-based vaccination to jumpstart clinically relevant anticancer immune responses.

100 项与 ADCV-01 相关的药物交易

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