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

Phase 2CompletedNCT01822093

Cell Medica Ltd8 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ADV Infection Post Allo-HSCT

Interventions

Cytovir-ADVBIOLOGICAL

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

Eligibility

Sex: ALLMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Great Ormond Street Hospital

London, United Kingdom

Royal Manchester Children's Hospital

Manchester, United Kingdom

Royal Victoria Infirmary

Newcastle, United Kingdom

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)

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

Data from ClinicalTrials.gov

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