A Phase II Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced with a Lentiviral Vector Carrying the FANCA Gene (Orphan Drug) in Patients with Fanconi Anemia Subtype A
Latest Information Update: 24 May 2024
At a glance
- Drugs Mozafancogene autotemcel (Primary)
- Indications Fanconi's anaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms FANCOLEN-II
- Sponsors Rocket Pharmaceuticals
- 06 Nov 2023 According to a Rocket Pharmaceuticals media release, Product filings for RP-L102 anticipated in the first half of 2024 in the U.S. and Europe. The company is finalizing the CMC package with the FDA.
- 04 Apr 2023 Planned End Date changed from 1 Jan 2023 to 1 Feb 2025.
- 04 Apr 2023 Planned primary completion date changed from 1 Jan 2023 to 1 Feb 2025.