Cullinan plans registrational Phase 2 trial for CLN-049
Cullinan Therapeutics will launch a potentially registrational Phase 2 trial of CLN-049 in relapsed/refractory AML in Q3 2026.
The plan follows positive FDA End-of-Phase 1 feedback, supporting a streamlined Phase 2 design aimed at defining dose then moving into a single-arm cohort.
Early results were previously presented at the 2025 ASH meeting, showing encouraging activity with a generally favorable safety profile.
An update from the ongoing dose-escalation study is scheduled for Q4 2026.
A separate Phase 1/2 combination study in previously untreated AML is also set to begin, pairing CLN-049 with standard therapies.
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