---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-310764"
form_type: "8-K"
ticker: "CGEM"
cik: "0001789972"
company_name: "Cullinan Therapeutics, Inc."
filed_at: "2025-12-08T23:59:59+00:00"
generated_at: "2026-05-16T14:01:56.967332+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Cullinan Therapeutics reports 31% CR/CRh rate at 12 µg/kg for CLN-049 in R/R AML Phase 1

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-310764
- form_type: 8-K
- ticker: CGEM
- cik: 0001789972
- company_name: Cullinan Therapeutics, Inc.
- filed_at: 2025-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1789972/000119312525310764/0001193125-25-310764-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1789972/000119312525310764/cgem-20251208.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-310764
- JSON: https://secwatch.observer/filing/0001193125-25-310764.json
- Plain text: https://secwatch.observer/filing/0001193125-25-310764.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.