A Pivotal, Randomized, Placebo-controlled, Double-blind, Multicenter, International Phase III Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-CVU on Wound Healing of Therapy-Resistant Non-Healing Chronic Venous Ulcers (CVU)

The aim of this clinical trial is to investigate the efficacy and safety of allo-APZ2-CVU, administered topically on therapy-resistant non-healing CVUs compared to placebo.

Start Date01 Sep 2024

Sponsor / Collaborator

RHEACELL GmbH & Co. KG

[+1]

NCT05838092 / RecruitingPhase 3

A Double-blind, Randomized, Placebo-controlled, Interventional, Multicenter, Phase III Clinical Trial to Investigate the Safety and Efficacy of ABCB5-positive Mesenchymal Stromal Cells (ABCB5+ MSCs) on Epidermolysis Bullosa (EB)

Start Date18 Oct 2023

Sponsor / Collaborator

RHEACELL GmbH & Co. KG

NCT05464381 / RecruitingPhase 3

The aim of this clinical trial is to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with recessive dystrophic epidermolysis bullosa (RDEB) compared to placebo. An additional baseline-controlled open-label arm will be included to investigate the safety and efficacy of allo-APZ2-OTS administered intravenously to subjects with JEB and to RDEB subjects < 1 year.

Start Date01 Feb 2023

Sponsor / Collaborator

RHEACELL GmbH & Co. KG

100 Clinical Results associated with APZ-2

100 Translational Medicine associated with APZ-2

100 Patents (Medical) associated with APZ-2

Literatures (Medical) associated with APZ-2

08 Dec 2017·Clinical and Experimental ImmunologyQ3 · MEDICINE

Detection of ABCB5 tumour antigen-specific CD8+ T cells in melanoma patients and implications for immunotherapy

Q3 · MEDICINE

Article

Author: Esterlechner, J ; Utikal, J ; Borchers, S ; Frank, M H ; Volkind, J ; Maβlo, C ; Müller, C A ; Kluth, M A ; Umansky, V ; Tahedl, A ; Ganss, C ; Nowak, Y

SummaryATP binding cassette subfamily B member 5 (ABCB5) has been identified as a tumour-initiating cell marker and is expressed in various malignancies, including melanoma. Moreover, treatment with anti-ABCB5 monoclonal antibodies has been shown to inhibit tumour growth in xenotransplantation models. Therefore, ABCB5 represents a potential target for cancer immunotherapy. However, cellular immune responses against ABCB5 in humans have not been described so far. Here, we investigated whether ABCB5-reactive T cells are present in human melanoma patients and tested the applicability of ABCB5-derived peptides for experimental induction of human T cell responses. Peripheral blood mononuclear cells (PBMNC) isolated from blood samples of melanoma patients (n = 40) were stimulated with ABCB5 peptides, followed by intracellular cytokine staining (ICS) for interferon (IFN)-γ and tumour necrosis factor (TNF)-α. To evaluate immunogenicity of ABCB5 peptides in naive healthy donors, CD8 T cells were co-cultured with ABCB5 antigen-loaded autologous dendritic cells (DC). ABCB5 reactivity in expanded T cells was assessed similarly by ICS. ABCB5-reactive CD8+ T cells were detected ex vivo in 19 of 29 patients, melanoma antigen recognised by T cells (MART-1)-reactive CD8+ T cells in six of 21 patients. In this small, heterogeneous cohort, reactivity against ABCB5 was significantly higher than against MART-1. It occurred significantly more often and independently of clinical characteristics. Reactivity against ABCB5 could be induced in 14 of 16 healthy donors in vitro by repeated stimulation with peptide-loaded autologous DC. As ABCB5-reactive CD8 T cells can be found in the peripheral blood of melanoma patients and an ABCB5-specific response can be induced in vitro in naive donors, ABCB5 could be a new target for immunotherapies in melanoma.

100 Deals associated with APZ-2

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Varicose Ulcer	Phase 3	IT	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	SE	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	PL	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	CZ	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	NL	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	HU	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	GB	RHEACELL GmbH & Co. KG	01 Sep 2024
Varicose Ulcer	Phase 3	SK	RHEACELL GmbH & Co. KG	01 Sep 2024
Epidermolysis Bullosa	Phase 3	AT	RHEACELL GmbH & Co. KG	01 Feb 2023
Epidermolysis Bullosa Dystrophica	Phase 3	US	RHEACELL GmbH & Co. KG	30 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03529877 (Pubmed \| JCI Insight) Manual	Phase 1/2	Epidermolysis Bullosa Dystrophica	16	ABCB5+ mesenchymal stem cells	kpuswmdtnc(mhzhvmcajx) = lyjprnjbmh yniqtsaozc (wvukenrllo ) View more	Positive	22 Nov 2021

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