← Back to Search

Gamma Delta T-Cell Infusion for Acute Myeloid Leukemia

Phase 1
Recruiting
Led By Marco Davila, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Free of symptomatic congestive heart failure or uncontrolled arrhythmia
Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial will test how effective and safe it is to give leukemia patients a single infusion of donor T-cells that have been expanded with Artificial Antigen Presenting Cells.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing Gamma Delta T-cell Infusion's safety and effectiveness as a single dose after an allogeneic hematopoietic cell transplant (alloHCT) in AML patients. It aims to find the maximum tolerated dose while assessing how well it prevents cancer from returning.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever or fatigue; complications from infusion like allergic reactions; increased risk of infection due to immune modulation; and possibly organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have heart failure symptoms or uncontrolled irregular heartbeats.
Select...
I am between 18 and 75 years old and am undergoing a specific stem cell transplant or treatment for a high-risk type of leukemia.
Select...
I am mostly able to care for myself and carry out normal activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Expansion: Leukemia Free Survival
Maximum Tolerated Dose
Secondary outcome measures
Number of Participants with Graft Versus Host Disease (GVHD)
Overall Survival (OS)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Treatment at Maximum Tolerated DoseExperimental Treatment1 Intervention
Participants will receive Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells at the dose determined to be the Maximum Tolerated Dose, administered as a single infusion
Group II: Dose Level 3Experimental Treatment1 Intervention
Participants will receive 1.0 x 108 cells/kg (0.75-1.25 x 108 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion
Group III: Dose Level 2Experimental Treatment1 Intervention
Participants will receive 2.5 x 107 cells/kg (1.875-3.125 x 107 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion
Group IV: Dose Level 1Experimental Treatment1 Intervention
Participants will receive 5.0 x 106 cells/kg (3.75-6.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion
Group V: Dose Level -1Experimental Treatment1 Intervention
Dose Level -1 may be used as a de-escalation dose level due to Dose Limiting Toxicities (DLTs) from Dose Level 1 Participants will receive 1.0 x 106 cells/kg (0.75-1.25 x 106 cells/kg) Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,460 Total Patients Enrolled
Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,971 Total Patients Enrolled
Marco Davila, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Gamma Delta T-Cell Infusion Clinical Trial Eligibility Overview. Trial Name: NCT05015426 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Dose Level -1, Dose Level 2, Dose Level 1, Dose Level 3, Treatment at Maximum Tolerated Dose
Acute Myeloid Leukemia Clinical Trial 2023: Gamma Delta T-Cell Infusion Highlights & Side Effects. Trial Name: NCT05015426 — Phase 1
Gamma Delta T-Cell Infusion 2023 Treatment Timeline for Medical Study. Trial Name: NCT05015426 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research incorporate seniors over the age of seventy?

"This specific medical trial is recruiting patients aged between 18 and 75. Alternatively, there are numerous trials available for those under the age of eighteen or above 65 years old; 450 studies accommodating younger individuals and 1231 that can be accessed by seniors."

Answered by AI

Has the FDA accepted the use of Gamma Delta T-Cell Infusion therapeutically?

"Gamma Delta T-Cell Infusion has only been studied minimally, so it scored a 1 in our safety assessment."

Answered by AI

How many individuals are being recruited for this clinical experiment?

"Affirmative. Per the information found on clinicaltrials.gov, this medical trial is presently enrolling patients. Initially posted on August 13th 2021 and most recently updated September 30th 2022, 32 participants are being recruited from a single location."

Answered by AI

Do I meet the requirements for inclusion in this trial?

"In order to join this clinical trial, potential participants must have a diagnosis of leukemia and be aged between 18-75. The team is looking for around 32 members in total."

Answered by AI

Are there any opportunities to volunteer for this clinical venture?

"Per the clinicaltrials.gov database, this is a current medical trial that was initiated on August 13th 2021 and most recently updated September 30th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT
2022. "Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05015426.
~8 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top