search
Back to results

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

Primary Purpose

ADV Infection Post Allo-HSCT

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Cytovir-ADV
Sponsored by
Cell Medica Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADV Infection Post Allo-HSCT

Eligibility Criteria

undefined - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients:

  1. Age 16 years or younger
  2. Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
  3. 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
  4. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.

Donors

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

Exclusion Criteria:

Patients

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

Donors

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

Sites / Locations

  • Great Ormond Street Hospital
  • Royal Manchester Children's Hospital
  • Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytovir-ADV

Arm Description

Adenovirus-specific T-cells

Outcomes

Primary Outcome Measures

Number of subjects with new onset GVHD
number of subjects developing NCI Grade 3-4 adverse events

Secondary Outcome Measures

Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)
Number of detectable HAdV-specific T-cells in vivo at each time point
Requirement for second infusion of HAdV-specific T-cells
Number of treatment days with antiviral drugs
Number of treatment days with other anti-infective drugs
Number of in-hospital days during 6 month post-infusion period

Full Information

First Posted
February 11, 2013
Last Updated
January 23, 2018
Sponsor
Cell Medica Ltd
Collaborators
Technology Strategy Board, United Kingdom
search

1. Study Identification

Unique Protocol Identification Number
NCT01822093
Brief Title
Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT
Acronym
ASPIRE
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cell Medica Ltd
Collaborators
Technology Strategy Board, United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADV Infection Post Allo-HSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cytovir-ADV
Arm Type
Experimental
Arm Description
Adenovirus-specific T-cells
Intervention Type
Biological
Intervention Name(s)
Cytovir-ADV
Other Intervention Name(s)
Adenovirus-specific T-cells
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of subjects with new onset GVHD
Time Frame
180 days
Title
number of subjects developing NCI Grade 3-4 adverse events
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)
Time Frame
180 days
Title
Number of detectable HAdV-specific T-cells in vivo at each time point
Time Frame
180 days
Title
Requirement for second infusion of HAdV-specific T-cells
Time Frame
180 days
Title
Number of treatment days with antiviral drugs
Time Frame
180 days
Title
Number of treatment days with other anti-infective drugs
Time Frame
180 days
Title
Number of in-hospital days during 6 month post-infusion period
Time Frame
180 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waseem Qasim
Organizational Affiliation
Institute of Child Health, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs