A multicenter, open-label, dose-escalation clinical trial to evaluate the safety of viral-specific T-cell (VST) therapy in the treatment of refractory viral infections after allogeneic hematopoietic stem cell transplantation (ALLOVISTA).

2024-517696-21-01 Protocol 2020/ABM/01/00125 Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites · Protocol 2020/ABM/01/00125

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 18
Countries 1
Sites 2

Resistant viral infections caused by cytomegalovirus (CMV) in adult patients after allogeneic hematopoietic stem cell transplantation.

Key facts

Sponsor
Wroclaw Medical University
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Decision date (initial)
2025-04-22
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Resistant viral infections caused by cytomegalovirus (CMV) in adult patients after allogeneic hematopoietic stem cell transplantation.

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wroclaw Medical University

5 Total trials 2 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Wroclaw Medical University
Address
Ul. Wybrzeze Ludwika Pasteura 1
City
Wroclaw
Postcode
50-367
Country
Poland

Scientific contact point

Organisation
Wroclaw Medical University
Contact name
Marek Ussowicz

Public contact point

Organisation
Wroclaw Medical University
Contact name
Marek Ussowicz

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Authorised, recruitment pending 18 2
Rest of world — 0 —

Investigational sites

Poland

2 sites · Authorised, recruitment pending
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-01-31 Poland Acceptable
2025-04-18
 2025-04-22