CAMBRIDGE, Mass. — October 8, 2026
Cullinan Therapeutics, Inc. announced that the first patient has been dosed in its planned registrational Phase 2 study of CLN-049 in patients with relapsed or refractory acute myeloid leukemia (AML). The investigational FLT3-directed T cell engager is being evaluated in a population with limited treatment options and poor outcomes following disease relapse or resistance to prior therapy.
Phase 2 Study Design and Patient Population
The study will evaluate CLN-049 in patients with relapsed or refractory AML who have received up to two previous lines of therapy. Following an end-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), the trial includes a dose-optimization phase evaluating two target dose levels, followed by a single-arm expansion cohort at the recommended Phase 2 dose. An exploratory cohort will also assess CLN-049 in patients with newly diagnosed TP53-mutated AML. Cullinan expects to provide an update from its Phase 1 dose-escalation study in December 2026.
FLT3-Directed T Cell Engager Approach
CLN-049 is an investigational FLT3×CD3 T cell engager designed to bind FLT3-expressing leukemia cells and engage CD3-positive T cells to promote targeted immune activity. The candidate binds both mutated and non-mutated FLT3, potentially supporting development across a broad AML patient population. CLN-049 has received FDA Orphan Drug and Fast Track designations for relapsed or refractory AML.
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Combination Trial Also Advancing
In parallel, Cullinan is initiating a Phase 1/2 study evaluating CLN-049 in combination with azacitidine and venetoclax in patients with newly diagnosed AML. The study will assess the combination’s safety, tolerability, pharmacokinetics and pharmacodynamics. Together, these clinical programs are intended to further characterize CLN-049’s potential in AML, including difficult-to-treat disease settings. Its safety and efficacy remain under clinical investigation.
Source::Cullinan Therapeutics, press release
