Cullinan doses first patient in planned registrational CLN-049 phase 2 leukemia trial
Published in Drugs development & discovery, Immunology.
October 8, 2026 — Cullinan Therapeutics announced that the first patient has received CLN-049 in a potentially registrational phase 2 study for relapsed or refractory acute myeloid leukemia (AML).
The investigational FLT3×CD3 T-cell engager is designed to connect immune T cells with FLT3-expressing leukemia cells. It targets both mutated and non-mutated FLT3, rather than requiring a particular FLT3 mutation.
According to the company, the study enrolls patients who have received up to two previous treatment lines. It begins by comparing two target doses, then moves into a single-arm expansion at the selected phase 2 dose. An exploratory cohort will study newly diagnosed AML with TP53 mutations.
This announcement marks trial initiation, not evidence that CLN-049 improves survival or remission rates. A single-arm expansion will also limit direct comparison with other treatments. Cullinan expects a separate phase 1 dose-escalation update in December 2026; CLN-049 remains investigational.
Source: Cullinan company announcement distributed by GlobeNewswire, October 8, 2026.