Clinical Trials /

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

NCT05015426

Description:

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT
  • Official Title: Phase 1/1b Trial of Donor γδ T--Cell Infusion for Treatment of Patients With Acute Myeloid Leukemia at High Risk of Relapse After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial IDs

  • ORG STUDY ID: MCC-20305
  • NCT ID: NCT05015426

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
Gamma Delta T-Cell InfusionDose Level -1

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Dose Level -1ExperimentalDose 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
  • Gamma Delta T-Cell Infusion
Dose Level 1ExperimentalParticipants 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
  • Gamma Delta T-Cell Infusion
Dose Level 2ExperimentalParticipants 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
  • Gamma Delta T-Cell Infusion
Dose Level 3ExperimentalParticipants 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
  • Gamma Delta T-Cell Infusion
Treatment at Maximum Tolerated DoseExperimentalParticipants 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
  • Gamma Delta T-Cell Infusion

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female, aged between 18 and 75 years of age undergoing allogeneic
             hematopoietic stem cell transplantation (alloHCT) or the treatment of Acute Myeloid
             Leukemia (AML) with detectable minimal residual disease (MRD) either before or after
             alloHCT

          -  Have < 5% blasts in bone marrow by morphology at the time of transplantation but
             pre-alloHCT flow cytometric or molecular evidence of MRD

          -  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

        Exclusion Criteria:

          -  Current use of concomitant systemic glucocorticoid 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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose
Time Frame:Up to 12 months
Safety Issue:
Description:Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells.

Secondary Outcome Measures

Measure:Number of Participants with Graft Versus Host Disease (GVHD)
Time Frame:at 6 weeks
Safety Issue:
Description:Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells
Measure:Overall Survival (OS)
Time Frame:Up to 12 months
Safety Issue:
Description:The length of time from start of treatment to death by any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • AML

Last Updated

August 30, 2021