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

Cell Medica

Status and phase: Completed; Phase 2; Phase 1

Conditions: ADV Infection Post Allo-HSCT

Treatments: Biological: Cytovir-ADV

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01822093

CM-2011-02

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: Under 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Cytovir-ADV

Experimental group

Description:

Adenovirus-specific T-cells

Treatment:

Biological: Cytovir-ADV