P1, N=18, Active, not recruiting, Cellenkos, Inc. | Trial completion date: Jan 2024 --> May 2024 | Trial primary completion date: Jan 2024 --> May 2024
10 months ago
Trial completion date • Trial primary completion date
Adoptive therapy with allogeneic, cord blood-derived regulatory T cells (Tregs) (CK0801- HLA 3/ 6 match, fresh infusion) showed safety and early clinical signal in MF (Kadia et al., Blood. The preliminary analysis of this study evaluating CK0804 (CXCR4 enriched T regs cell therapy) as addition to ruxolitinib shows initial safety with no myelosuppressive adverse events and promising clinical activity. The study is actively enrolling participants (NCT05423691). MD Anderson Cancer Center has an institutional conflict of interest with Cellenkos related to the research presented herein.
This is the first study to show that a single infusion of allogeneic CB derived Treg cells (CK0801) is well tolerated, feasible, and may be associated with clinical improvement in patients with immune related bone marrow disorders. Determining the optimal dose and schedule of the Treg cell infusion is ongoing.