Last updated on June 2019

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


Brief description of study

This is a multicenter prospective randomized phase IIa/II Expansion clinical trial designed to determine the MTD (Maximum Tolerated Dose) of CD24Fc for acute GVHD (Graft Versus Host Disease) prophylaxis.

Funding Source - FDA OOPD

Detailed Study Description

This is a multicenter prospective randomized Phase IIa with a Phase II expansion cohort clinical trial designed to determine the RP2D or MTD of CD24Fc for acute GVHD prophylaxis. Phase IIa is a randomized double blind trial comprised of: i) 2 single ascending dose cohorts of 8 patients (3:1 treatment:placebo); and ii) a multi-dosing cohort consisting of 8 patients (3:1 treatment:placebo) that will receive 3 consecutive biweekly administrations of CD24Fc. The multi-dose cohort will be initiated prior to enrolling the highest single dose (960 mg) cohort and the total dose administered will be equal to the highest single dose. The total planned enrollment for the Phase IIa portion is 32 subjects. If CD24Fc demonstrates safety and tolerability in Phase IIa, the trial will proceed to a 20 patient expansion cohort. All other components of the allogeneic HCT process will be according to routine institutional practice. This trial will exclusively utilize unrelated donors that receive myeloablative conditioning regimens and attempt to improve upon standard GVHD prophylaxis with tacrolimus and methotrexate. In the single dose cohorts, the study agent, CD24Fc, will be administered as a single dose on day -1 pre-transplant. In the multi dose cohort the patients CD24Fc will be administered on days -1, 14 and 28.

The Phase II expansion will utilize unrelated donors that receive pre-defined myeloablative conditioning regimens and attempt to improve upon standard GVHD prophylaxis with tacrolimus and methotrexate. In the Phase II expansion cohort, the study agent, CD24Fc, will be administered on days -1, 14, and 28 at the dose of 480mg, 240 mg and 240mg, respectively, as established in Phase IIa.

Clinical Study Identifier: NCT02663622

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Recruitment Status: Open


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