Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia
Key Highlights
- ➤First patient dosed in pivotal Phase 2 CLN-049 study for relapsed/refractory AML
- ➤Study follows successful End-of-Phase 1 meeting with the U.S. FDA
- ➤Phase 2 includes dose optimization and seamless single-arm expansion cohort
- ➤Company expects Phase 1 dose-escalation update in December
- ➤Cullinan initiating Phase 1/2 CLN-049 combination study in newly diagnosed AML
Expert Statements
Jeffrey Jones, Chief Medical Officer of Cullinan Therapeutics
“Patients with relapsed or refractory AML continue to face poor outcomes and limited treatment options, underscoring the urgent need for new treatment approaches that can benefit a broad range of patients.”
Jeffrey Jones, Chief Medical Officer of Cullinan Therapeutics
“We believe CLN-049 has the potential to offer a novel immunotherapeutic approach for patients with AML.”
Jeffrey Jones, Chief Medical Officer of Cullinan Therapeutics
“With this Phase 2 study now underway, we look forward to further evaluating the potential role of CLN-049 for this difficult-to-treat disease.”
CAMBRIDGE, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that the first patient has been dosed in its pivotal Phase 2 study of CLN-049, a novel, investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia (AML).
“Patients with relapsed or refractory AML continue to face poor outcomes and limited treatment options, underscoring the urgent need for new treatment approaches that can benefit a broad range of patients,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “We believe CLN-049 has the potential to offer a novel immunotherapeutic approach for patients with AML. With this Phase 2 study now underway, we look forward to further evaluating the potential role of CLN-049 for this difficult-to-treat disease.”
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