SYF93faa534313443da9f6a20ae70585f10Registry ID: 2024-520084-14-00|RecruitingPhase 1/2
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interventional
N/A
1 country
2
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January 22, 2025
Actual (reported)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.
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.
General University Hospital Of Patras
Patras, 265 04, Greece
Geniko Nosokomeio Thessalonikis George Papanikolaou
Thessaloniki, 570 10, Greece
Alexandros Spyridonidis
First Submitted
January 22, 2025
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