IL-21 Expanded Natural Killer Cells for Leukemia
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any concurrent therapy like chemotherapy, targeted therapy, radiation therapy, or immunotherapy for your leukemia while participating in this trial.
What data supports the effectiveness of the treatment Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells for leukemia?
Research shows that natural killer (NK) cells expanded with membrane-bound interleukin-21 (IL-21) can grow significantly and become highly effective at killing cancer cells, including leukemia cells. In clinical trials, these expanded NK cells have been shown to improve patient outcomes by reducing relapse rates and increasing survival in leukemia patients.12345
Is the treatment with IL-21 expanded NK cells safe for humans?
How is the treatment with IL-21 Expanded Natural Killer Cells for Leukemia different from other treatments?
This treatment uses natural killer (NK) cells expanded with membrane-bound interleukin-21 (IL-21), which allows for a large-scale production of highly active NK cells. These cells are more effective in targeting leukemia cells compared to traditional methods, and the treatment is designed to reduce the risk of leukemia relapse after stem cell transplantation.13456
Research Team
Sumithira Vasu, MBBS
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with recurrent or treatment-resistant acute myeloid leukemia (AML) who weigh at least 42 kg, have a decent heart function and performance status, controlled seizures if present, acceptable liver and kidney functions, no active graft-versus-host disease or uncontrolled infections. They must not be on high-dose steroids or have had recent investigational therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive fludarabine and cytarabine, followed by six doses of NK cells
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sumithira Vasu
Lead Sponsor
Kiadis Pharma
Industry Sponsor