Cullinan Therapeutics (CGEM) said Monday that data from its early-stage trial evaluating the CLN-049 monotherapy candidate in acute myeloid leukemia and myelodysplastic syndrome showed "promising" efficacy, including multiple complete responses.
For acute myeloid leukemia, the company said the complete response to complete remission with partial hematologic recovery rate was 31%, at the highest target dose tested to date.
Efficacy endpoints of the study include complete response rate and composite complete response rate, the company said.
Initial dose escalation results in 45 patients demonstrated a favorable safety profile across all doses assessed, the company said.
Development of CLN-049 will proceed under the US Food and Drug Administration's Fast Track designation, the company said.
Dose escalation is continuing in this ongoing phase 1 study, with expansion groups planned in early 2026, it added.
Shares of the company were up 12% in recent Monday trading.
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