other material
confidence high
sentiment positive
materiality 0.80
Cullinan Therapeutics reports 31% CR/CRh rate at 12 µg/kg for CLN-049 in R/R AML Phase 1
Cullinan Therapeutics, Inc.
- At 12 µg/kg (n=16), CR/CRh rate 31% (5/16) and CRc rate 31% (5/16); at ≥6 µg/kg (n=32), CR/CRh 25% and CRc 28%.
- In TP53-mutated AML patients at 12 µg/kg, 50% (4/8) achieved CR/CRh; 3 of 4 responses durable >16 weeks.
- 63% (5/8) of responders at ≥6 µg/kg had response >16 weeks; 2 patients proceeded to transplant.
- Safety: CRS mostly Grade 1/2 (35.6%), no Grade 3 with two step-up doses; no discontinuations due to CRS.
- FDA granted Fast Track designation; dose escalation continues with expansion cohorts planned early 2026.