virus-specific immunotherapy

Phase 1

• Conditions: Patients undergoing allogeneic HSCT undergo weekly screening for HAdV and CMV PCR. In case of viraemia = 100 copies/ml PB preemptive antiviral with either Gancyclovir or Cidofovir conform to the local HSCT-infection-SOPs. In case of increasing viral load despite adequte virostatic treatment for two weeks, the administration of donor derived (or receipient derived in case of donor CMV negativity and receipient positivity before HSCT) virus specific T cells is foreseen; MedDRA version: 18.1 Level: LLT Classification code 10050541 Term: Cytomegalovirus antigen positive System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-002492-17-AT
• Lead Sponsor: St. Anna Kinderkrebsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-03
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Children and adolescents (0-18 years) who undergo any type of allogeneic stem cell transplantation at the St Anna Children`s Hospital, Vienna.
• Informed consent is signed
• Presence of HAdV or CMV-specific T-cells in the donor or CMV-specific T-cells in the recipient pre-transplant
• Stable (= 10E6) or increasing viraemia despite antiviral treatment post HSCT
• Absence of virus-specific T cells post transplant
• Karnofsky / Lansky score >50%
• Pregnancy excluded

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Infusion of polyclonal or monoclonal T-cell directed antibodies within 28 days before seVirus T-Cell infusion
•Multiple organ failure at screening-timepoint seVirus T-Cell infusion
•History of GvHD Gr III-IV or actual GvHD Gr III-IV
•Pregnancy
•Treatment with granulocyte transfusion within the last 72 hours
•Karnofsky / Lansky score <50%
•Subject is unwilling or unable to comply with the study procedures
•High dose treatment with steroids (= 2mg/kg/d, methylprednisone-equivalent)

Study & Design

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