Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT ( VS-TC )

Phase 1

• Conditions: 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; MedDRA version: 20.1Level: PTClassification code 10056559Term: Graft infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2021-005150-28-IT
• Lead Sponsor: IRCCS ISTITUTO GIANNINA GASLINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-26
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Allogeneic transplant with any cells source and conditioning regimen
• Age between 0-21 years
• Viral infection/reactivation (CMV, EBV, ADV)
• Resistance of viral infections to treatments
• 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;
• Presence of informed consent to the treatment of the patient / parent /legal
guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified