Overview

This trial is active, not recruiting.

Condition adv infection post allo-hsct
Treatment cytovir-adv
Phase phase 1/phase 2
Sponsor Cell Medica Ltd
Collaborator Technology Strategy Board, United Kingdom
Start date December 2012
End date December 2016
Trial size 15 participants
Trial identifier NCT01822093, CM-2011-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Adenovirus-specific T-cells
cytovir-adv Adenovirus-specific T-cells
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 Outcomes

Measure
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

Measure
Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)
time frame: 180 days
Number of detectable HAdV-specific T-cells in vivo at each time point
time frame: 180 days
Requirement for second infusion of HAdV-specific T-cells
time frame: 180 days
Number of treatment days with antiviral drugs
time frame: 180 days
Number of treatment days with other anti-infective drugs
time frame: 180 days
Number of in-hospital days during 6 month post-infusion period
time frame: 180 days

Eligibility Criteria

Male or female participants up to 16 years old.

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

Additional Information

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
Principal investigator Waseem Qasim
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Cell Medica Ltd.