Gamma Delta T-Cell Infusion for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment using special immune cells called Gamma Delta T-Cells to assist people with Acute Myeloid Leukemia (AML) after a stem cell transplant. The main goal is to determine the safest dose and assess its effectiveness. Different groups in the trial receive varying doses to identify the most effective one. Suitable candidates for this trial have AML, are undergoing a stem cell transplant, and are currently in good health without serious heart or infection issues. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.
Do I need to stop my current medications for the trial?
The trial requires that you stop using systemic glucocorticoids (a type of steroid medication) before the T-cell infusion. If you have had GVHD (a complication after a transplant), you must be off prednisone (a steroid) for at least 14 days before the infusion.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that gamma delta T-cell infusions are usually safe for people. One study demonstrated high cell viability, meaning the cells remained alive and active, and found very low contamination from other cell types—less than 0.06%—indicating good purity and safety.
Another study examined doses up to 108 cells per kilogram and found them safe for patients, with no serious safety issues reported. This suggests that gamma delta T-cells can be administered safely at certain doses.
While this trial aims to find the maximum safe dose, existing research indicates these treatments have been safe in past studies. However, new data from this trial could provide more detailed insights into safety.12345Why are researchers excited about this trial's treatment?
Unlike the standard chemotherapy treatments for acute myeloid leukemia (AML), Gamma Delta T-Cell Infusion introduces a unique approach by harnessing the power of the immune system. This treatment uses Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells to target and attack cancer cells directly. Researchers are particularly excited about this method because gamma delta T-cells can recognize and destroy leukemia cells without the need for prior antigen exposure. This potentially reduces the risk of severe side effects common with traditional chemotherapy, offering a more targeted and safer alternative for patients battling AML.
What evidence suggests that this trial's treatments could be effective for Acute Myeloid Leukemia?
Research has shown that gamma delta T-cells, a type of immune cell, may help treat Acute Myeloid Leukemia (AML). Studies have found that these cells can extend patient survival and reduce the risk of leukemia recurrence. In trials, gamma delta T-cells remained alive and active, which is crucial for combating cancer. Patients with higher levels of a specific type of these cells, known as Vγ9Vδ2 T-cells, demonstrated better survival rates. This trial will explore various dose levels of gamma delta T-cell infusion to determine the most effective and safe dosage for treating AML.12567
Who Is on the Research Team?
Nelli Bejanyan, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with Acute Myeloid Leukemia who are undergoing or have undergone a stem cell transplant and are at high risk of relapse. Participants must be in good physical condition, not pregnant, willing to use contraception, and able to follow the study procedures for its duration. They cannot join if they have uncontrolled infections, leukemia relapse after transplant, recent other treatments, active severe graft-versus-host disease (GVHD), or are using steroids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single infusion of AAPC-expanded donor T-cells at various dose levels to determine the maximum tolerated dose
Follow-up
Participants are monitored for safety, effectiveness, and overall survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gamma Delta T-Cell Infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Florida Department of Health
Collaborator