Phase 1 Study of CLN-049 Drug for Patients With Relapsed or Refractory Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS Using IV or SC Administration

What this Trial Is About

Researchers are evaluating CLN-049, a bispecific T cell engager targeting FLT3 and CD3, in adults with relapsed or refractory Acute Myeloid Leukemia AML or Myelodysplastic Syndrome MDS. This Phase 1, open-label trial aims to assess the safety and preliminary pharmacokinetics of CLN-049, including its effects on treatment-emergent adverse events and drug levels in the body over 28 days. The study is sponsored by Cullinan Therapeutics Inc. and involves patients who have not responded to or cannot tolerate existing therapies. The trial is divided into three parts Part A involves a single ascending dose of CLN-049 given intravenously IV followed by 28 days of safety monitoring. Part B includes multiple ascending IV doses administered weekly after an initial lead-in dose, with 28 days of safety follow-up and up to 2 years of long-term monitoring. Part C uses weekly subcutaneous SC injections of CLN-049 with the same follow-up schedule as Part B. The SC injection groups will begin first, then the IV groups, allowing comparison of administration methods. Participants will undergo regular evaluations including monitoring for adverse events, laboratory tests, and pharmacokinetic assessments such as maximum and trough drug levels. Safety is closely followed for 28 days after dosing, with long-term follow-up for up to 2 years to track ongoing effects. The study measures include immune response to CLN-049 and detailed blood tests. Overall participation duration may extend depending on the assigned treatment part and follow-up needs.

CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)