Clinical trial • Phase III • Haematology|Rare Disease
CTX112 for Relapsed/Refractory Hematologic Autoimmune Disease | Warm autoimmune hemolytic anemia | Immune thrombocytopenic purpura
Phase III trial of CTX112 for Relapsed/Refractory Hematologic Autoimmune Disease | Warm autoimmune hemolytic anemia | Immune thrombocytopenic purpura.
Overview
- Trial Therapeutic Area
- Haematology|Rare Disease
- Trial Disease
- Relapsed/Refractory Hematologic Autoimmune Disease | Warm autoimmune hemolytic anemia | Immune thrombocytopenic purpura
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 31-10-2025
- First CTIS Authorization Date
- 12-03-2026
Trial design
Phase III trial in Germany, Spain.
- Target Sample Size
- 45
Eligibility
Recruits 45 Vulnerable population selected (isVulnerablePopulationSelected=true) in record; no further details on consent or assent handling provided in source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true) in record; no further details on consent or assent handling provided in source.
Recruitment
- Planned Sample Size
- 45
- Recruitment Window Months
- 53
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 45
Germany
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 77
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- II. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Eva Maria Wagner-Drouet
- Principal Investigator Email
- Eva.Wagner@unimedizin-mainz.de
- Contact Person Name
- Eva Maria Wagner-Drouet
- Contact Person Email
- Eva.Wagner@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Innere Medizin I
- Principal Investigator Name
- Ruth Flümann
- Principal Investigator Email
- ruth.fluemann@uk-koeln.de
- Contact Person Name
- Ruth Flümann
- Contact Person Email
- ruth.fluemann@uk-koeln.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
- Principal Investigator Name
- Christian Schultze-Florey
- Principal Investigator Email
- Schultze-Florey.Christian@mh-hannover.de
- Contact Person Name
- Christian Schultze-Florey
- Contact Person Email
- Schultze-Florey.Christian@mh-hannover.de
Spain
- Earliest CTIS Part Ii Submission Date
- 11-02-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 69
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Hematology
- Principal Investigator Name
- Clara Aparicio
- Principal Investigator Email
- clara.aparicio.sspa@juntadeandalucia.es
- Contact Person Name
- Clara Aparicio
- Contact Person Email
- clara.aparicio.sspa@juntadeandalucia.es
Sponsor
Primary sponsor
- Full Name
- CRISPR Therapeutics AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- CTX112
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