Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD (NCT02406651) | Clinical Trial Compass
CompletedPhase 1/2
Study of IL-22 IgG2-Fc (F-652) for Subjects With Grade II-IV Lower GI aGVHD
United States30 participantsStarted 2016-05-12
Plain-language summary
A Phase IIa single arm open-label study to investigate the safety, tolerability, and PK of F-652 in combination with systemic corticosteroids in subjects who have undergone Hematopoietic Stem Cell Transplantation (HSCT) and have newly diagnosed grade II-IV lower GI acute Graft Verses Host Disease (aGVHD). Treatment with F-652 will be once a week for 4 weeks, with post treatment follow up visits on days 28, 56, 180 and 365.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years and ≤80.
✓. Newly diagnosed lower GI grade II-IV aGVHD with clinical diagnosis based on modified Keystone criteria1 following allogeneic HSCT using bone marrow, peripheral blood stem cells, or cord blood. Grading of aGVHD will be based on International Bone Marrow Transplant Registry (IBMTR) criteria.
✓. Subjects are willing to undergo a biopsy to confirm lower GI aGVHD. Biopsy results are not needed to initiate treatment. However, if aGVHD is not confirmed histologically, treatment with F-652 will be discontinued.
✓. Female subjects of childbearing potential who agree to practice 2 effective methods of contraception.
✓. Male subjects, even if surgically sterilized (i.e. Status post-vasectomy) must agree to agree to practice contraception.
✓. Have adequate renal function (Serum creatinine \<3 mg/dL).
✓. ANC \>500/mm3.
✓. Show evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
Exclusion criteria
✕. Evidence of relapse or progression of hematologic malignancy at the time of study enrollment.
✕. Active uncontrolled infection. Subjects with a controlled infection receiving definitive therapy for 48 hours prior to enrollment were eligible.
What they're measuring
1
The Number of Participants With Lower Gastrointestinal Acute Graft-Versus-Host-Disease Treatment Response Rate on Day 28
. Subjects requiring vasopressors or mechanical ventilation.
✕. Subjects who had received previous systemic corticosteroids for the treatment of acute GI GVHD for longer than 5 days. Subjects who were treated with systemic corticosteroids for aGVHD for a prior allogeneic HSCT \>12 months ago were eligible.
✕. Subjects who received any corticosteroid therapy (for non-GVHD) at doses \>0.5 mg/kg/day prednisone (or IV equivalent) within 7 days prior to the onset of GVHD therapy.
✕. Subjects who developed aGVHD after unplanned donor lymphocyte infusion.
✕. Subjects with chronic GVHD features (i.e., acute/chronic GVHD overlap syndrome or classical chronic GVHD).