Clinical TrialJul 28, 2026, 07:02 AM
Cullinan to Initiate Registrational Phase 2 Study for CLN-049 in AML
AI Summary
Cullinan Therapeutics, Inc. announced positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 meeting for CLN-049, its FLT3xCD3 T cell engager for acute myeloid leukemia (AML). Based on these discussions, the company plans to initiate a potentially registrational Phase 2 study for CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026, with a study design agreed upon with the FDA. Additionally, Cullinan will begin a Phase 1/2 study evaluating CLN-049 in combination with venetoclax and azacitidine for previously untreated AML.
Key Highlights
- Cullinan received positive FDA feedback for CLN-049 after End-of-Phase 1 meeting.
- Company to initiate potentially registrational Phase 2 study for CLN-049 in relapsed/refractory AML in Q3 2026.
- FDA-agreed study design includes dose-optimization and seamless progression to single-arm cohort.
- CLN-049 previously demonstrated promising clinical activity and favorable safety in Phase 1.
- Cullinan will also initiate a Phase 1/2 combination study for CLN-049 in untreated AML.
- CLN-049 has received Orphan Drug and Fast Track designations from the U.S. FDA.
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