Cullinan Therapeutics doses first patient in Phase 2 trial of CLN-049 for relapsed/refractory AML
Cullinan Therapeutics announced that the first patient was dosed in its pivotal Phase 2 study of the FLT3xCD3 engager CLN-049 for relapsed or refractory acute myeloid leukemia. The trial will begin with a dose‑optimization segment testing two dose levels before moving to a single‑arm expansion at the recommended Phase 2 dose. An exploratory cohort will evaluate the drug in newly diagnosed TP53‑mutated AML, and a separate Phase 1/2 combination study with azacitidine and venetoclax is also being launched. The company expects a data update from its ongoing Phase 1 dose‑escalation study in December.
Why it matters
The start of a potentially registrational Phase 2 trial reduces development risk for Cullinan and may support future valuation, but the stock fell 2.62% to $15.22 after the announcement. The company also indicated it will provide an efficacy update in December.
Key facts
- 1Cullinan Therapeutics dosed the first patient in a pivotal Phase 2 trial of CLN-049 on Oct. 8, 2026. globenewswire.com
- 2The trial enrolls relapsed or refractory AML patients who have received up to two prior lines of therapy. rttnews.com
- 3After a dose‑optimization stage testing two target dose levels, the study will advance to a single‑arm expansion at the recommended Phase 2 dose. globenewswire.com
- 4An exploratory cohort will assess CLN‑049 in newly diagnosed TP53‑mutated AML. rttnews.com
- 5Cullinan plans to release data from its ongoing Phase 1 dose‑escalation study in December. globenewswire.com
- 6CLN‑049 has been awarded both Orphan Drug and Fast Track status by the U.S. FDA. rttnews.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.