NCT01822093
Completed
Phase 1
Phase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation
Cell Medica Ltd3 sites in 1 country8 target enrollmentStarted: December 2012Last updated:
ConditionsADV Infection Post Allo-HSCT
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cell Medica Ltd
- Enrollment
- 8
- Locations
- 3
- Primary Endpoint
- Number of subjects with new onset GVHD
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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
- •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
- •Pregnant or lactating females
- •(assessed prior to apheresis) Platelets \< 50x109/L
Outcomes
Primary Outcomes
Number of subjects with new onset GVHD
Time Frame: 180 days
number of subjects developing NCI Grade 3-4 adverse events
Time Frame: 180 days
Secondary Outcomes
- Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)(180 days)
- Number of treatment days with other anti-infective drugs(180 days)
- Number of detectable HAdV-specific T-cells in vivo at each time point(180 days)
- Requirement for second infusion of HAdV-specific T-cells(180 days)
- Number of treatment days with antiviral drugs(180 days)
- Number of in-hospital days during 6 month post-infusion period(180 days)
Investigators
Study Sites (3)
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