Skip to main content
OpenTrials
Completed

NCT Number: NCT01822093

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ADV Infection Post Allo-HSCT

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Great Ormond Street Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • Age 16 years or younger
  • Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
  • The subject (or legally acceptable representative) must give informed consent (and assent for subjects ≥ 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent
  • Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.

Donors

  • Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein
  • Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG
  • Passed medical assessment for stem cell donation
  • HdADV seropositive
  • Signed informed consent
  • Age 16 years or older

Exclusion criteria

Patients

  • Pregnant or lactating females
  • Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
  • Human Immunodeficiency Virus (HIV) infection

Donors

  • Pregnant or lactating females
  • (assessed prior to apheresis) Platelets < 50x109/L

Treatment and study plan

Cytovir-ADV

Biological

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

Other names: Adenovirus-specific T-cells

Primary outcomes

  1. Number of subjects with new onset GVHD

    Time frame: 180 days

  2. number of subjects developing NCI Grade 3-4 adverse events

    Time frame: 180 days

Secondary outcomes

  1. Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)

    Time frame: 180 days

  2. Number of detectable HAdV-specific T-cells in vivo at each time point

    Time frame: 180 days

  3. Requirement for second infusion of HAdV-specific T-cells

    Time frame: 180 days

  4. Number of treatment days with antiviral drugs

    Time frame: 180 days

  5. Number of treatment days with other anti-infective drugs

    Time frame: 180 days

  6. Number of in-hospital days during 6 month post-infusion period

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Cell Medica Ltd

Industry

Collaborators

  • Technology Strategy Board, United Kingdom

Registry information

Official study title

Phase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation

Acronym: ASPIRE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 2, 2013
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.