Cellenkos Receives US FDA IND Clearance for CK0802 Phase 1b/ 2a Trial in GVHD
The US Food and Drug Administration (FDA) clears Cellenkos Inc IND for CK0802, a first-in-class off-the-shelf Treg therapy, advancing to a phase 1b/2a trial in steroid-refractory Graft-Versus-Host Disease (GVHD).
Cellenkos | 06/05/2026 | By News Bureau
US FDA Grants Orphan Drug Designation to CK0804 Treg Therapy of Cellenkos
The US FDA has granted Orphan Drug Designation to Cellenkos’ CK0804, a first-in-class CXCR4hi Treg therapy for myelofibrosis. The investigational therapy is designed to home to the bone marrow and spleen, where it modulates inflammation through in-vivo expansion and IL-10 secretion.
Cellenkos | 07/01/2026 | By News Bureau | 134
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