Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT

NCT05015426 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MCC-203059BC08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose

  Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells.

  Up to 12 months

• Dose Expansion: Leukemia Free Survival

  Leukemia-free survival is defined as the time from the date of start of treatment to the date of relapse of AML or death from any cause

  Up to 12 months

Secondary Outcomes (2)

• Number of Participants with Graft Versus Host Disease (GVHD)

  at 6 weeks

• Overall Survival (OS)

  Up to 12 months

Study Arms (5)

Dose Level -1

EXPERIMENTAL

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

Biological: Gamma Delta T-Cell Infusion

Dose Level 1

EXPERIMENTAL

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

Biological: Gamma Delta T-Cell Infusion

Dose Level 2

EXPERIMENTAL

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

Biological: Gamma Delta T-Cell Infusion

Dose Level 3

EXPERIMENTAL

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

Biological: Gamma Delta T-Cell Infusion

Treatment at Maximum Tolerated Dose

EXPERIMENTAL

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

Biological: Gamma Delta T-Cell Infusion

Interventions

Gamma Delta T-Cell Infusion BIOLOGICAL

Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT.

Dose Level -1; Dose Level 1; Dose Level 2; Dose Level 3; Treatment at Maximum Tolerated Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have \< 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed
• Karnofsky performance status (KPS) ≥ 70% during the study screening.
• Free of symptomatic congestive heart failure or uncontrolled arrhythmia
• Adequate organ function as defined per protocol
• Negative serum pregnancy test
• Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Agreement to adhere to Lifestyle Considerations throughout study duration

You may not qualify if:

• 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).
• Uncontrolled serious infection.
• Morphologic relapse of leukemia at any timepoint after HCT.
• Active central nervous system malignancy.
• Pregnancy or lactation.
• Treatment with another investigational drug or other intervention within 14 days of T-cell infusion

Sponsors & Collaborators

• Florida Department of Health: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nelli Bejanyan, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: March 21, 2022
• Primary Completion: August 30, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)