Clinical trial • Phase I • Oncology|Haematology
REM-422 (MYB mRNA degrader) for Relapsed/refractory acute myeloid leukaemia|Higher-risk myelodysplastic syndrome
Phase I trial of REM-422 (MYB mRNA degrader) for Relapsed/refractory acute myeloid leukaemia|Higher-risk myelodysplastic syndrome.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Relapsed/refractory acute myeloid leukaemia|Higher-risk myelodysplastic syndrome
- Trial Stage
- Phase I
- Drug Modality
- Oligonucleotide
Key dates
- Initial CTIS Submission Date
- 27-03-2024
- First CTIS Authorization Date
- 08-07-2024
Trial design
open-label, none/not specified-controlled Phase I trial across 4 sites in France.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 60
Eligibility
Recruits 60 Vulnerable population selected (isVulnerablePopulationSelected=true); no further details on consent or assent handling provided in the available documents..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no further details on consent or assent handling provided in the available documents.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 60
France
- Earliest CTIS Part Ii Submission Date
- 21-06-2024
- Latest Decision Or Authorization Date
- 15-09-2025
- Processing Time Days
- 451
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hématologie - Immunologie
- Contact Person Name
- Raphael Itzykson
- Contact Person Email
- raphael.itzykson@aphp.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Hématologie
- Contact Person Name
- Stéphane De Botton
- Contact Person Email
- stephane.debotton@gustaveroussy.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Oncologie médicale - Unité de phases précoces
- Contact Person Name
- Pierre Bories
- Contact Person Email
- bories.pierre@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hématologie Clinique et Thérapie Cellulaire
- Contact Person Name
- Arnaud Pigneux
- Contact Person Email
- arnaud.pigneux@chu-bordeaux.fr
Sponsor
Primary sponsor
- Full Name
- Remix Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- REM-422
- Active Substance
- REM-422 (MYB mRNA degrader)
- Modality
- Oligonucleotide
- Authorisation Status
- Investigational product (not authorised)
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