Manufacture of Clinical T-cell Products for Future Treatment

Study Overview
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Brief Summary
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The aim of this pilot study is to validate the manufacture of T-cell products using GMP-approved reagents for future clinical use. Lymphocytes from whole blood of max 300ml from volunteers or from total 9 volunteer apheresates will be isolated to validate the protocol under Good Manufacturing Practice (GMP).

Detailed Description
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Viral diseases occur in up to 50% of patients after transplantation. In most cases, there is a reactivation of the virus, which can be found latent or dormant in the body's own cells. The main reason for the occurrence of these diseases is the limited T-cell immunity, which serves to control these viruses in healthy people. To date, there are few effective and, depending on the virus, no established therapies. In addition, the established therapies are often associated with considerable toxicity. An alternative therapy, which has already shown success in the 1990s, is the administration of virus-specific T cells. Adoptive T cell therapies for the major pathogens emerging post-transplant are intended to use. In order to be used as therapy these cells must be manufactured under Good Manufacturing Practice (GMP). Leukapheresis from whole blood of maximum 300ml is used to generate the virus-specific T cells. These cells are examined for purity and specificity and are used for scientific purposes only. The aim of this study is to validate the manufacture of T-cell products using GMP-approved reagents for future clinical use.

Official Title
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Pilot Study to Manufacture Clinical T-cell Products for Future Treatment

Conditions
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Virus-specific T Cells

Intervention / Treatment
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* Other: Leukapheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed consent Immunoglobulins (Ig) G available for Epstein-Barr virus (EBV) or cytomegalovirus (CMV) Detectable T-cell response for EBV or CMV measured by flow cytometry (> 0.01%) Exclusion Criteria: Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or human T-cell lymphoma virus (HTLV)-I/II

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Leukapheresis|Leukapheresis to isolate 1x10e9 cells, examined for purity and specificity under Good Manufacturing Practice (GMP)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukapheresis for manufacturing of T cell products by Good Manufacturing Practice (GMP) | Number of leukapheresis to isolate 1x10e9 cells for manufacturing of T cell products by Good Manufacturing Practice (GMP) | one time assessment during the procedure | 
| Purity after isolation defined as > 40% interferon-gamma positive cells | Purity after isolation defined as > 40% interferon-gamma positive cells | one time assessment during the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T cell immunity, adoptive T cell therapy, Good Manufacturing Practice (GMP), leukapheresis