None listed
Conditions
Interventions
Product Name: Streptacells - CMV specific donor lymphocytes enriched by means of StreptamerMHC immunomagnetic sepa
Pharmaceutical Form: Intravenous infusion
Sponsors
Stage Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 - healthy CMV-seropositive donor who had donated the stem cells in the first place and who will also be considered to donate the CMV-specific lymphocytes - matched unrelated donor (third party donor) if donor who had donated stem cells is CMV seronegative - Streptamer reagents for HLA-typ of patient available - donor and patient agreed to participate in the trial Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - immunosuppressive treatment with > 1mg/kg prednisolon - acute graft versus host disease grade III or IV at time point of transfer - missing written consent of donor and/or patient - diseases affecting the haelth of donor or patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Toxicity Safety and toxicity of a adoptive immunetherapy with Streptamer isolated T lymphocytes of the bone marrow or peripheral stem cell donor;Secondary Objective: Effectivity Redution in viral load, viral elimination Induction of CMV-specific T-cell response in the recipient;Primary end point(s): Drop in CMV viral load in the circulation estimated by PCR | — |
Countries
Germany
Outcome results
None listed