Hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
Conditions
Interventions
Product Name: e?d??? ?-?eµf???tt???? ??a t? ?e?ape?a ???µ??e?? ap? AdV, CMV, EBV, BKV ?a? Aspergillus fumigatus
Product Code: Penta-STs-001
Pharmaceutical Form: Solution for injection
Sponsors
Ge???? ??s???µe?? Tessa??????? "Ge?????? ?apa????????"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant. 2)Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ??V and AF (see 2.2.1 definitions). 3)Karnofsky/Lansky score of = 50. 4)ANC > 500/µl. 5)Bilirubin = 2x*, AST 8.0 g/dl. 6)Pulse oximetry of > 90% on room air. 7)Available pentavalent-specific T cells. 8)Negative pregnancy test (if female of childbearing potential) 9)Patient capable of providing informed consent. Are the trial subjects under 18? no 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1)Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days. 2)Steroids > 0.5 mg/kg/day prednisone. 3)Received donor lymphocyte infusion in last 28 days. 4)GVHD = grade 2. 5)Active and uncontrolled relapse of malignancy. 6)Patients with other uncontrolled infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the feasibility and safety of administering rapidly-generated donor-derived Penta-STs in HSCT recipients with viral or/and fungal reactivation or infection. The second primary objective is to determine the effect of Penta-STs infusion on pathogen load, reconstitution of antiviral and antifungal immunity post-infusion and clinical responses.;Secondary Objective: there are no secondary objectives;Primary end point(s): The primary objectives, for this phase I/II study are: 1) the determination of the safety of cell therapy with penta-STs. The primary endpoint will be the safety of cell therapy with penta-STs. will be assessed according to: i) acute GvHD grades III-IV within 6 weeks of the last dose of penta-STs, ii) grades =3 infusion-related adverse events iii) grades =3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/co-morbidities or the original malignancy. 2)The efficacy of penta-STs, which will be determined based on: •pathogen loads and clinical symptoms in patients. •reconstitution of antiviral and antifungal immunity •viral reactivations or recurrence of AF infection post penta-STs infusion. ;Timepoint(s) of evaluation of this end point: 1)Safety will be assessed according to: i) acute GvHD grades III-IV within 6 weeks of the last dose of penta-STs, ii) grades =3 infusion-related adverse events iii) grades =3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/co-morbidities or the original malignancy. 2)Patients will be followed for acute toxicity for 30 days, acute and chronic GVHD for 6 weeks and 6 months respectively, anti-viral and antifungal responses for 6 months following the final VSTs infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ?/?;Timepoint(s) of evaluation of this end point: ?/? | — |
Countries
Greece
Contacts
Public ContactG?a????? ??a??e??a
??µat??????? ???????, ????da ?etaµ?s?e?s?? ??µ?p???t???? ??tt????, ??s???µe?? G. ?apa????????, Tessa??????
Outcome results
None listed