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

ADV Infection Post Allo-HSCT Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822093
• Other study ID #: CM-2011-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 11, 2013
• Last updated: January 23, 2018
• Start date: December 2012
• Est. completion date: December 31, 2016

Study information

• Verified date: January 2018
• Source: Cell Medica Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• ADV Infection Post Allo-HSCT

Intervention

Biological:
• Cytovir-ADV
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

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London
United Kingdom	Royal Manchester Children's Hospital	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
Cell Medica Ltd	Technology Strategy Board, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with new onset GVHD		180 days
Primary	number of subjects developing NCI Grade 3-4 adverse events		180 days
Secondary	Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)		180 days
Secondary	Number of detectable HAdV-specific T-cells in vivo at each time point		180 days
Secondary	Requirement for second infusion of HAdV-specific T-cells		180 days
Secondary	Number of treatment days with antiviral drugs		180 days
Secondary	Number of treatment days with other anti-infective drugs		180 days
Secondary	Number of in-hospital days during 6 month post-infusion period		180 days