NCT05713513

Manufacture of Clinical T-cell Products for Future Treatment

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Virus-specific T Cells

Interventions

Type	Name	Description
OTHER	Leukapheresis	Leukapheresis to isolate 1x10e9 cells, examined for purity and specificity under Good Manufacturing Practice (GMP)

Timeline

• Start date: 2019-07-24
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2023-02-06
• Last updated: 2023-02-06

Locations

1 site across 1 country: Switzerland