Clinical trial NCT01822093: Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ADV Infection Post Allo-HSCT
Lead sponsor: Cell Medica Ltd
Sponsor class: INDUSTRY
Collaborators: name: Technology Strategy Board, United Kingdom
First posted: 2013-04-02
Enrollment: 8
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with new onset GVHD
timeFrame: 180 days
measure: number of subjects developing NCI Grade 3-4 adverse events
timeFrame: 180 days
Secondary outcomes:
measure: Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)
timeFrame: 180 days
measure: Number of detectable HAdV-specific T-cells in vivo at each time point
timeFrame: 180 days
measure: Requirement for second infusion of HAdV-specific T-cells
timeFrame: 180 days
measure: Number of treatment days with antiviral drugs
timeFrame: 180 days
measure: Number of treatment days with other anti-infective drugs
timeFrame: 180 days
measure: Number of in-hospital days during 6 month post-infusion period
timeFrame: 180 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Institute of Child Health, London
name: Waseem Qasim
role: PRINCIPAL_INVESTIGATOR
References: