Gamma Delta T-Cell Infusion for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byNelli Bejanyan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

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.

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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.

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Treatment Details

Interventions

Gamma Delta T-Cell Infusion (CAR T-cell Therapy)

Trial OverviewThe 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

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