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 v
Conditions
Interventions
Product Name: virus specific T cells
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: VIRUS SPECIFIC T-CELLS
Concentra
Sponsors
St. Anna Kinderkrebsforschung
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1.: 48 hours after infusion 2. and 3.: 8 weeks after infusion ; Main Objective: 1. Primary: Evaluation of feasibility, safety and potential side effects of short-term expanded HAdV- and CMV-specific T- cells (seVirus-T-cells) in patients with HAdV and/or CMV viraemia not responding to antiviral therapy after allogeneic HSCT. • Acute toxicity (Grade III-IV) of seVirus-T-cell infusion within 48 hours from infusion • De novo acute GvHD > Gr II or increase of pre-existing GvHD more than 1 grade from 2 weeks post infusion until 8 weeks post infusion • incidence of graft rejection ; Secondary Objective: 2. Secondary: Detection of virus-specific T-cells within 8 weeks after T-cell therapy. Measurement of the viral load following the infusion of seVirus-T-cells Correlation of the presence of virus-specific T-cells with partial reduction (>1 log viral copies /ml blood) or complete clearance of viral load. Tracking of the infused seVirus-T-cells by NGS of the TCRs ; Primary end point(s): • Non pre-existing Immune System Disorders i.e. Allergic reaction, Anaphylaxis, Cytokine release syn-drome or Serum sickness of Grade III-IV) of seVirus-T-cell infusion within 48 hours from infusion • De novo acute GvHD > Gr II or increase of pre-existing GvHD more than 1 grade from 2 weeks post infusion until 8 weeks post infusion • Incidence of graft rejection (within 8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 6 months after infusion; Secondary end point(s): 1. Detection of virus-specific T-cells within 8 weeks after T-cell therapy. Measurement of the viral load following the infusion of seVirus-T-cells 2. Correlation of the presence of virus-specific T-cells with partial reduction (>1 log viral copies /ml blood) or complete clearance of viral load. 3. Tracking of the infused T-cells by NGS of the TCRs. | — |
Countries
Austria
Contacts
Public ContactRuth Ladenstein
SIRP
Outcome results
None listed