Overview
Sponsor-declared trial summary
Patients who have received an allogeneic haematopoietic stem cell transplant and who have developed post-transplant viral reactivation (CMV, Adenovirus, EBV) resistant to pharmacological therapies.
The aim of the study is to evaluate the safety of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV), BK that developed in young patients (age between 0 and 30 years) after allogeneic hematopoi…
Key facts
- Sponsor
- IRCCS Istituto Giannina Gaslini
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Jul 2024 → ongoing
- Decision date (initial)
- 2025-01-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518925-14-02
- EudraCT number
- 2021-005150-28
- ClinicalTrials.gov
- NCT05075837
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The aim of the study is to evaluate the safety of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV), BK that developed in young patients (age between 0 and 30 years) after allogeneic hematopoietic cell transplantation (allo-HSCT).
Secondary objectives 1
- To evaluate the effectiveness of the PTC infusion in controlling the clinical and biological manifestations secondary to the viral infection being treated
Conditions and MedDRA coding
Patients who have received an allogeneic haematopoietic stem cell transplant and who have developed post-transplant viral reactivation (CMV, Adenovirus, EBV) resistant to pharmacological therapies.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10056559 | Graft infection | 100000004862 |
| 20.0 | SOC | 10021881 | Infections and infestations | 1 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518925-14-00 | Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | IRCCS Istituto Giannina Gaslini |
| 2024-518925-14-01 | Virus-specific T-cell Immunity for the Treatment of Some Resistant Viral Infections After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | IRCCS Istituto Giannina Gaslini |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Allogeneic transplant with any cells source and conditioning regimen
- Presence of informed consent to the treatment of the patient / parent /legal guardian
- Age between 0-30 years
- Viral infection/reactivation (CMV, EBV, ADV, BK)
- Absence of concomitant severe uncontrolled infections
- Life expectancy exceeding 30 days
- Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD)
- Absence of acute kidney damage (creatinine value> 3 times the value normal with respect to age) not related to viral infection
- Absence of severe acute liver injury (direct bilirubin> 3mg / dl or glutamicoxaloacetic transaminase -SGOT> 500 UI/L) not related to viral infection
Exclusion criteria 4
- Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test)
- Patient with severe renal and/or hepatic impairment as specified above
- Primary or secondary graft failure
- Relapse of malignant underlying disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Adverse events: To collect any adverse event defined as any significant alteration of vital signs and / or organ function, expressed in clinical, hematochemical and radiological findings according to version 5 of the Common Terminology Criteria for Adverse Events (CTCAE)
Secondary endpoints 1
- Organ damage; overall survival; specific cell viral immunity; variation of viremia.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Giannina Gaslini
- Sponsor organisation
- IRCCS Istituto Giannina Gaslini
- Address
- Via Gerolamo Gaslini 5
- City
- Genoa
- Postcode
- 16147
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Giannina Gaslini
- Contact name
- Maura Faraci
Public contact point
- Organisation
- IRCCS Istituto Giannina Gaslini
- Contact name
- Maura Faraci
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-07-17 | 2025-01-31 | 2025-07-22 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Italy | Acceptable 2025-01-27
|
2025-01-31 |