Cullinan Therapeutics CLN-049 复发/难治 AML 关键 II 期试验完成首例患者给药

Cullinan Moves CLN-049 Into Phase 2 Development For Relapsed/Refractory AML
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Biotech Daily Dose
Cullinan Moves CLN-049 Into Phase 2 Development For Relapsed/Refractory AML
By
RTTNews Staff Writer
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Published:
10/8/2026 9:43 AM ET
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Cullinan Therapeutics (
CGEM
) announced Thursday that the first patient has been dosed in its pivotal Phase 2 study of CLN-049 in patients with relapsed or refractory acute myeloid leukemia (AML).
Acute myeloid leukemia is a cancer of the blood and bone marrow characterized by the rapid growth of abnormal white blood cells. Patients with relapsed or refractory AML continue to face limited treatment options and poor outcomes.
CLN-049 is an investigational FLT3xCD3 T cell engager designed to target FLT3-expressing leukemia cells. The treatment binds to both mutated and non-mutated FLT3, potentially allowing it to be used regardless of FLT3 mutational status.
The potentially registrational Phase 2 study will evaluate CLN-049 in patients with relapsed or refractory AML who have received up to two prior lines of therapy. Following a dose-optimization phase evaluating two target dose levels, the study will advance to a single-arm expansion cohort at the recommended Phase 2 dose.
The study also includes an exploratory cohort evaluating CLN-049 in patients with newly diagnosed TP53-mutated AML. Cullinan expects to provide an update from its ongoing Phase 1 dose-escalation study in relapsed or refractory AML in December.
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.
CLN-049 is also being evaluated in patients with relapsed or refractory AML or myelodysplastic syndrome in an ongoing Phase 1/2 study assessing safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy.
CLN-049 has received Orphan Drug and Fast Track designations from the U.S. FDA for the treatment of relapsed or refractory AML.
CGEM has traded between $6.50 and $23.19 over the past year.
The stock is currently trading at $15.22, down 2.62%%.
For comments and feedback contact: editorial@rttnews.com
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