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Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT

NCT01822093 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-01-25

No results posted yet for this study

Summary

Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a Phase I/IIa open-label safety study, assessing the effects of administering adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem cell transplant.

Conditions

  • ADV Infection Post Allo-HSCT

Interventions

BIOLOGICAL

Cytovir-ADV

A single dose 1x10e4 CD3+ T cells/kg patient weight of Cytovir ADV is prescribed to patients on exhibiting two consecutive PCR positive Adenovirus viraemia results \> 1000 copies/ml. Patients are followed up by continued monitoring of Adenovirus viraemia results. If patients exhibit uncontrolled ADV viraemia at ≥ 4 weeks following the first cell dose, they will be prescribed a second cell dose of 10e5 CD3+ T cell/kg. Patients will be monitored for 6 months following infusion of Cytovir ADV. This is a feasibility/pilot study and has no control group

Sponsors & Collaborators

  • Technology Strategy Board, United Kingdom

    collaborator OTHER

  • Cell Medica Ltd

    lead INDUSTRY

Principal Investigators

  • Waseem Qasim · Institute of Child Health, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822093 on ClinicalTrials.gov