Last updated on February 2020

Phase II Trial of CD24Fc for the Prevention of Acute GVHD Following Myeloablative Allogeneic HSCT


Brief description of study

This is a multicenter prospective phase IIa dose escalation and Phase II expansion cohort clinical trial designed to determine the efficacy of CD24Fc for acute GVHD prophylaxis.

Detailed Study Description

The first part of study is a Phase IIa randomized, double blind, placebo controlled, multi-center study to investigate adding CD24Fc to standard of care tacrolimus and methotrexate in acute graft-versus host disease (GVHD) prophylaxis for allogeneic hematopoietic stem cell transplantation (HCT) with matched unrelated donors in treatment of leukemia and myelodysplastic syndrome. Three dose cohorts are planned with 240 mg at day -1, 480 mg at day -1, and the multi-dose cohort of 480-240-240 mg at day -1, day 14 and day 28. The CD24Fc : placebo ratio is 3:1.

The second part is a prospective phase II expansion cohort trial investigating the addition of CD24Fc to standard acute graft-versus host disease (GVHD) prophylaxis for allogeneic hematopoietic stem cell transplantation (HCT). Based on the Phase IIa safety results and the pharmacokinetic data, the Phase II expansion dose will be the multi-dose 480-240-240 mg regimen administered on day -1, day 14 and day 28. The primary objective of phase II expansion is to determine if the addition of CD24Fc to standard GVHD prophylaxis improves 180 days grade III-IV acute GVHD-free survival (AGFS) when compared to CIBMTR database registered control patients who had standard GVHD prophylaxis alone. Eligible patients will be those requiring allogeneic HCT for malignant hematologic conditions and receiving a myeloablative conditioning regimen. An unrelated donor is required to match at HLA-A, -B, -C, and -DRB1 loci.

Clinical Study Identifier: NCT02663622

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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