Phase 1 Trial of T Cell Therapy Combined With DCAML Fusion Vaccine, Decitabine, and Venetoclax for Treating Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating a new treatment approach for people with acute myeloid leukemia AML, including those with AML in relapse. This phase 1 clinical trial aims to test the safety, feasibility, and immune effects of a combination therapy using adoptive T cell therapy with dendritic cell DCAML primed T cells, a DCAML fusion vaccine, and standard drugs decitabine and venetoclax. This is the first time DCAML primed T cells and DCAML fusion vaccine are being given to humans, while decitabine, venetoclax, and GM-CSF are approved treatments for AML. Participants receive treatment in multiple cycles. Initial cycles 1-2 involve decitabine given daily for 5 days and venetoclax daily for 21 days. After bone marrow biopsy and leukapheresis, dose escalation of T cells occurs in cycles 5-7 with continued decitabine and venetoclax, plus infusion of DCAML primed T cells, DCAML fusion vaccine, and GM-CSF on specific days. The study uses a dose escalation method to find the maximum tolerated dose of T cells. Follow-up visits happen monthly for 6 months, then every 3 months for 2 years, and yearly for 3 more years. During the trial, participants undergo blood tests, bone marrow biopsy, and leukapheresis to collect immune cells. Researchers closely monitor for treatment side effects including toxicity, infections, and immune reactions over several years. They measure outcomes such as successful manufacture and administration of vaccine-educated T cells, maximum tolerated dose, toxicity rates, relapse-free survival, minimal residual disease conversion, and overall survival. Participation may last years due to long-term follow-up for safety and effectiveness.

Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML