Gamma Delta T-Cell Infusion for Acute Myeloid Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Systemic glucocorticoids

Disqualifiers: Active GVHD, Uncontrolled infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).

Research Team

Nelli Bejanyan, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

Negative serum pregnancy test

Agreement to adhere to Lifestyle Considerations throughout study duration

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

Exclusion Criteria

I am not currently taking any steroid medications.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of AAPC-expanded donor T-cells at various dose levels to determine the maximum tolerated dose

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and overall survival after treatment

Up to 12 months

Treatment Details

Interventions

• Gamma Delta T-Cell Infusion

Trial Overview 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.

Participant Groups

Group I: Treatment at Maximum Tolerated Dose Experimental Treatment 1 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 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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 -1 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+