CLN-049 - (Florentine)

October 8, 2026: Cullinan Therapeutics (NASDAQ: CGEM) said the first patient has been dosed in a pivotal Phase 2 study of CLN-049, an investigational FLT3xCD3 T-cell engager, in relapsed/refractory acute myeloid leukemia (AML). After a successful End-of-Phase 1 FDA meeting, the potentially registrational trial will test two target dose levels in a brief dose-optimization phase, then move seamlessly into a single-arm expansion cohort at the recommended Phase 2 dose. The study also includes an exploratory cohort in newly diagnosed TP53-mutated AML.

Cullinan said it expects an update in December from the Phase 1 dose-escalation study of CLN-049 in relapsed/refractory AML. In parallel, the company is initiating a Phase 1/2 study of CLN-049 in combination with azacitidine and venetoclax in newly diagnosed AML (NCT07722767).

CLN-049 is also being evaluated in an ongoing Phase 1/2 open-label, multiple ascending dose study in relapsed/refractory AML or myelodysplastic syndrome (NCT05143996). The company noted CLN-049 has received FDA Orphan Drug and Fast Track designations for relapsed/refractory AML.