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An open-label, multi-center, first in human, phase 1/2a trial to evaluate the safety and preliminary efficacy of autologous tolerogenic dendritic cells ex vivo loaded with recombinant Factor VIII (FVIII) in adults with congenital Hemophilia A (HA) with neutralizing antibodies to FVIII and having failed Immune Tolerance Induction (ITI)

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Trial Profile

An open-label, multi-center, first in human, phase 1/2a trial to evaluate the safety and preliminary efficacy of autologous tolerogenic dendritic cells ex vivo loaded with recombinant Factor VIII (FVIII) in adults with congenital Hemophilia A (HA) with neutralizing antibodies to FVIII and having failed Immune Tolerance Induction (ITI)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Mar 2023

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At a glance

  • Drugs IDO 8 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms Toler8
  • Sponsors Idogen

Most Recent Events

  • 24 Feb 2023 According to an Idogen Media release, company will pause the clinical trial in the IDO 8 program as the company currently do not have sufficient capital
  • 12 Dec 2022 According to an Idogen Media release, abstract of this trial had been submitted to the 64th annual meeting of the American Society of Hematology (ASH) within the category of Clinical Trial in Progress. It has now been digitally published in the supplement to the November edition of Blood.
  • 05 Sep 2022 According to an Idogen Media release, first patient is planned to be included during autumn.

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