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# Cellenkos IND Approved for Phase 1 T-Cell Therapy
- URL: https://www.fdaweb.com/cellenkos-ind-approved-for-phase-1-t-cell-therapy/
- Published: 2018-06-11T12:00:00.000Z
- Updated: 2026-09-15T00:12:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141654

FDA has approved a Cellenkos IND to proceed with a Phase 1 clinical trial of CK0801, third-party cord blood-derived regulatory T cells, in patients with bone marrow failure syndrome including aplastic anemia, myelodysplastic syndrome and myelofibrosis. The trial of CK0801 will begin in the third quarter at the University of Texas MD Anderson Cancer Center in Houston. “CK0801 works to replace and replenish the defective regulatory T cells and blocks the uncontrolled inflammatory signal generated by the cytotoxic T cells against patients' own tissues,” the company says. “Such an approach may lead to calming of the bone marrow inflammatory microenvironment as a result of the infused CK0801 which may then lead to the reversal of the hematopoietic arrest that will potentially translate into clinical improvement.”