NCT04901416

Safety and Efficacy of Allogeneic NK Cell Infusions in Patients With Relapsed/Refractory AML and High Risk MDS

An Open-Label Pilot Study to Evaluate the Safety and Efficacy of DVX201 NK Cells in Patients With Relapsed or Refractory AML or High Risk MDS or High Risk Overlapping Myelodysplastic / Myeloproliferative Neoplasms

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Coeptis Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study involves the use of an investigational cell therapy known as DVX201. DVX201 is an investigational cell therapy that contains a type of white blood cell called natural killer (NK) cells. NK cells are a normal part of your immune system and have a lifespan of only about two weeks. They are called natural killer cells because they have the natural ability to identify and kill cells in the body that are abnormal, like cancer cells or virally infected cells. But fighting cancer can also lead to exhaustion and abnormal function of NK cells. It can also result in a significant decrease in the number of NK cells in the blood, making it more difficult for the immune system to control the disease. We believe that infusion of healthy, functional NK cells into patients with AML or MDS may boost the immune system and help by killing cancer cells that remain after chemotherapy. DVX201 is an investigational NK cell therapy that may provide a rapid and temporary source of healthy NK cells that are better able to fight those cancer cells.

Conditions

• AML, Adult Recurrent
• MDS

Interventions

Type	Name	Description
BIOLOGICAL	DVX201	Based upon the occurrence of DLT (does limiting toxicity), the MTD will be estimated as the highest dose at which the toxicity probability is the closest to the target probability (denoted pT=0.30) following up to 2 doses of DVX201. The corresponding dose allocation methodology is a modified toxicity interval design based upon (Ji et al., 2010; Ji et al., 2013). All patients who have at least one dose initiated will be included in the safety analysis. Patients who are enrolled but never exposed to investigational product will be replaced for all analyses. Patients who get exposed to lymphodepleting chemotherapy will be followed and reported for outcomes overall, but for determination of safety and efficacy, only those subjects who have been exposed to the investigational agent will be included.

Timeline

• Start date: 2021-12-15
• Primary completion: 2023-10-15
• Completion: 2024-06-04
• First posted: 2021-05-25
• Last updated: 2024-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study