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

Phase 1

Completed

• Conditions: ADV Infection Post Allo-HSCT
• Interventions: Biological: Cytovir-ADV

• Registration Number: NCT01822093
• Lead Sponsor: Cell Medica Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cytovir-ADV	Cytovir-ADV	Adenovirus-specific T-cells

Primary Outcome Measures

Name	Time	Method
Number of subjects with new onset GVHD	180 days
number of subjects developing NCI Grade 3-4 adverse events	180 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Great Ormond Street Hospital; 🇬🇧 London, United Kingdom

Royal Victoria Infirmary; 🇬🇧 Newcastle, United Kingdom

Royal Manchester Children's Hospital; 🇬🇧 Manchester, United Kingdom