Adoptive immune therapy of chemotherapy-refractory CMV-infection with Streptamer-selected T-cells after allogeneic bone marrow- or peripheral blood stem cell transplantatio

Phase 1

Recruiting

• Conditions: B25.9; Cytomegaloviral disease, unspecified

• Registration Number: DRKS00000205
• Lead Sponsor: Stage Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

patient planned for or after allogeneic bone marrow or peripheral blood stem cell transplantation with a chronic persistent CMV infection refractory to antiviral chemotherapy,

reagents for HLA-type of patient available,

CMV seropositive donor,

patient agreed to participate in the trial

Exclusion Criteria

missing written consent of patient and /or donor,

medication with > 1mg/kg Prednisolon,

acute or chronic Graft versus Host disease grade III or IV

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint of the study are acute infusion-related side effects (e.g. anaphylactic reaction) and the development of a graft versus host disease

Secondary Outcome Measures

Name	Time	Method
A) Reduction or elimination of viremia <br>Determination of antiviral effect of the transferred CMV-specific T-cells in the patient will be assessed through PCR-measurement of virus copies and counting of CMV-specific CD8+ T-cells. The data will provide evidence for the CMV-specific immune reconstitution in the patient<br>B) Induction of a CMV-specific CD8+ T-cell response. <br>Generation of a long lasting immune response of the bone marrow/stem cell recipient against CMV through the adoptive transfer of CMV-specific CD8+ T-cells.