Adopt immunotherapy in adult patients undergoing hematopoietic stem cell (HSCT) transplantation from a fully compatible donor sibling for the prevention and treatment of GvHD.
Conditions
Brief summary
To define the safety, tolerability, and maximum tolerable dose (MTD) of iG-Tregs for GvHD prophylaxis (Time frame: until 90 days following the infusion): - Incidence of infusion toxicity (within 1 hour of the infusion and graded according to CTCAE v. 4), Additional toxicities that may occur related to iG-Treg infusion (eg. Occurrence of exacerbation of GvHD, infections, disease relapse), Adverse effects occurring during the first 3 weeks following iG- Treg infusion will be accounted for the assessment of the safety profile and tolerability of each dose during the dose escalation phase (dose limiting toxicities, DLTs). One iG-Treg dose will be considered safe if DLT occurs only in 1/6 or 0/3 subjects of each cohort.
Detailed description
Clinical efficacy of iG-Treg infusion in GvHD prophylaxis (Time frame: 52 weeks following allo-HCT): 1. Incidence and severity of GvHD, Day of cyclosporine (CsA) cessation, Treatment failure (includes the diagnosis GvHD, inability to cease CsA administration until d+150 following allo-HCT, disease relapse), Patients receiving iG-Tregs will be compared to a cohort not receiving the infusion of with retrospective data.
Interventions
DRUGΕπαγόμενα HLA-G+ Τ-ρυθμιστικά κύτταρα (iG-Tregs)
Sponsors
University Of Patras, University Of Patras
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the safety, tolerability, and maximum tolerable dose (MTD) of iG-Tregs for GvHD prophylaxis (Time frame: until 90 days following the infusion): - Incidence of infusion toxicity (within 1 hour of the infusion and graded according to CTCAE v. 4), Additional toxicities that may occur related to iG-Treg infusion (eg. Occurrence of exacerbation of GvHD, infections, disease relapse), Adverse effects occurring during the first 3 weeks following iG- Treg infusion will be accounted for the assessment of the safety profile and tolerability of each dose during the dose escalation phase (dose limiting toxicities, DLTs). One iG-Treg dose will be considered safe if DLT occurs only in 1/6 or 0/3 subjects of each cohort. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy of iG-Treg infusion in GvHD prophylaxis (Time frame: 52 weeks following allo-HCT): 1. Incidence and severity of GvHD, Day of cyclosporine (CsA) cessation, Treatment failure (includes the diagnosis GvHD, inability to cease CsA administration until d+150 following allo-HCT, disease relapse), Patients receiving iG-Tregs will be compared to a cohort not receiving the infusion of with retrospective data. | — |
Countries
Greece
Outcome results
None listed