Safety and Dose Evaluation of SEA-CD70 Alone and with Azacitidine in Adults with Myelodysplastic Syndrome and Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and dosing of a drug called SEA-CD70 alone and in combination with azacitidine in adults with myelodysplastic syndrome MDS and acute myeloid leukemia AML. This phase 1, open-label study aims to understand the side effects, tolerability, pharmacokinetics, and antitumor activity of SEA-CD70 in patients with these myeloid malignancies. The study includes several parts to address different patient groups and treatment combinations based on disease status and prior therapies. The study has seven parts Part A will determine the appropriate SEA-CD70 dose for relapsed or refractory MDS Parts B and C will evaluate safety and effectiveness of SEA-CD70 monotherapy in relapsedrefractory MDS and AML, respectively. Parts D, E, and F will explore SEA-CD70 combined with azacitidine for various MDS or MDSAML patient groups, including untreated higher-risk and relapsed cases. Part G will assess SEA-CD70 with azacitidine and venetoclax in untreated AML patients unfit for standard chemotherapy. Treatments include intravenous SEA-CD70 on Days 1 and 15 of each cycle, azacitidine given subcutaneously or intravenously on Days 1 to 7, and continuous oral venetoclax when applicable. Participants will undergo regular assessments of side effects, laboratory tests, and dose-limiting toxicities during treatment cycles lasting up to approximately two years, with some outcomes followed for up to four years. The study tracks pharmacokinetics and antitumor responses, including remission rates and survival measures. Safety is closely monitored up to 30-37 days after the last dose. The total participation duration varies depending on the study part and treatment response, with multiple visits scheduled for treatment administration and monitoring.

A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies