NEXI-001 + Decitabine for AML or MDS

This trial tests a new treatment for individuals with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that has returned or not responded after a bone marrow transplant. The treatment combines NEXI-001 (a therapy where immune cells are modified to attack cancer), decitabine (a drug that helps create normal blood cells and kills abnormal ones), and chemotherapy. The trial aims to determine the safest dose and identify any side effects. Eligible participants have AML or MDS that returned or didn't respond after a matched donor bone marrow transplant. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients receiving systemic corticosteroids or other immunosuppressant agents at the time of initiation of chemotherapy are excluded, so you may need to discuss your specific medications with the trial team.

Research shows that NEXI-001, a type of T cell therapy, has been tested for safety and tolerability. Early results from other studies indicate that patients with AML (Acute Myeloid Leukemia) or MDS (Myelodysplastic Syndromes) generally tolerate this treatment well. Some patients have experienced mild to moderate side effects, while serious side effects remain rare.

Research has found decitabine to be relatively safe for treating AML and MDS. It helps produce normal blood cells and targets abnormal ones. Although some patients may experience low blood cell counts, it is generally considered effective with manageable side effects.

Researchers are excited about NEXI-001 for treating acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) because it offers a novel approach compared to standard chemotherapy and hypomethylating agents like azacitidine and decitabine alone. NEXI-001 utilizes a unique mechanism by harnessing the power of T cells to specifically target and attack cancer cells, which could lead to improved outcomes. Additionally, its combination with decitabine and lymphodepletion chemotherapy may enhance its effectiveness by creating an optimal environment for the T cells to function. This innovative strategy has the potential to provide a more targeted treatment with fewer side effects than traditional therapies.

In this trial, participants will receive a combination of NEXI-001, an advanced cell therapy, and Decitabine. Studies suggest that NEXI-001 holds promise for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Early results indicate that these specially designed cells can enhance the immune system's ability to attack cancer cells, particularly in patients whose cancer has returned or who do not respond to treatment after a stem cell transplant. Decitabine, used alongside NEXI-001 in this trial, has proven effective and safe for treating AML and MDS. It helps produce normal blood cells while targeting abnormal ones. The combination aims to prepare and support the body in fighting these blood cancers.¹²⁴⁶⁷