Virus-specific ImmunoTherapy Following Allogeneic Stem Cell Transplantation

NCT02702427 | Withdrawn Phase 1 DMC

• 1 other identifier: Eudra CT2013-002492-17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Invasive infections with CMV and Adenovirus, not responding to virostatic treatment are treated with virusspecific donor derived or autologous virusspecific T-cells.

Conditions

Cytomegalovirus Infection; Adenovirus Infection

Keywords

viral infections post HSCT, virus-specific T-cells

Outcome Measures

Primary Outcomes (3)

• Non pre-existing Immune System Disorders i.e. Allergic reaction, Anaphylaxis, Cytokine release syndrome or Serum sickness of Grade III-IV of seVirus-T-cell infusion within 48 hours from infusion

  assessment is performed according to CTCAE 4.3 Scale

  48 hours

• 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

  assessment is performed according to Glucksberg Scale, modified for paediatic patients from D. Jacobsohn (publication Blood 2008)

  8 weeks

• Incidence of graft rejection

  8 weeks

Secondary Outcomes (3)

• 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

  6 months

• Correlation of the presence of virus-specific T-cells with partial reduction (>1 log viral copies /ml blood) or complete clearance of viral load

  8 weeks

• Tracking of the infused T-cells by NGS (Next Generation Sequencing) of the TCRs (T-Cell Receptors)-beta rearrangements

  3 months

Study Arms (1)

ARM 1

EXPERIMENTAL

Patients with Adenovirus or CMV infection after HSCT and no reduction of viral disease or stable disease with 10E6 viral copies within 2 weeks of antiviral treatment will receive a single infusion of virus-specific T-Cells

Biological: virus-specific T-Cells

Interventions

virus-specific T-Cells BIOLOGICAL

infusion

ARM 1

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age at timepoint of HSCT ≤18 years undergoing allogeneic stem cell transplantation
• 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 viremia despite antiviral treatment post HSCT
• Absence of HAdV or CMV -specific T cells post HSCT
• Karnofsky / Lansky score \>50%
• Pregnancy excluded
• Informed study participation consent is signed

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Anna Kinderkrebsforschung: lead

Study Sites (1)

St. Anna Children's Hospital

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cytomegalovirus Infections; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Susanne Matthes, MD

  St. Anna Kinderkrebsforschung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 8, 2016
• Study Start: August 3, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)