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Gamma Delta T-Cell Infusion for Acute Myeloid Leukemia

Phase 1

Waitlist Available

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

Must not have

Current use of concomitant systemic glucocorticoid at the time of γδ T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function

Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I do not have heart failure symptoms or uncontrolled irregular heartbeats.

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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.

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I am mostly able to care for myself and carry out normal activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking any steroid medications.

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I have active grade II-IV acute GVHD and haven't taken prednisone for at least 14 days.

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I have an active brain or spinal cord tumor.

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I do not have any serious infections that are not under control.

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My leukemia has returned after a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Expansion: Leukemia Free Survival

Maximum Tolerated Dose

Secondary study objectives

Number of Participants with Graft Versus Host Disease (GVHD)

Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met