Clinical trial • Phase I • Infectious Disease
Viral-specific T-cells for Cytomegalovirus (CMV) infection | Refractory viral infections after allogeneic hematopoietic stem cell transplantation
Phase I trial of Viral-specific T-cells for Cytomegalovirus (CMV) infection | Refractory viral infections after allogeneic hematopoietic stem cell transpl…
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Cytomegalovirus (CMV) infection | Refractory viral infections after allogeneic hematopoietic stem cell transplantation
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 31-01-2025
- First CTIS Authorization Date
- 22-04-2025
Trial design
open-label, none/not specified-controlled, adaptive Phase I trial across 2 sites in Poland.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation (Phase I) design; no detailed adaptive rules, dose-escalation schema, interim analyses or stopping rules provided in the available documents.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 18
Recruitment
- Planned Sample Size
- 18
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 18
Poland
- Earliest CTIS Part Ii Submission Date
- 11-02-2025
- Latest Decision Or Authorization Date
- 22-04-2025
- Processing Time Days
- 70
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Contact Person Name
- Anna Czyż
- Contact Person Email
- a.czyz@umw.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Contact Person Name
- Lidia Gil
- Contact Person Email
- lidia.gil@skpp.edu.pl
Sponsor
Primary sponsor
- Full Name
- Wroclaw Medical University
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- Viral-specific T-cell (VST) therapy
- Active Substance
- Viral-specific T-cells
- Modality
- Cell therapy
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