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

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gamma Delta T-Cell Infusion
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Level -1

Dose Level 1

Dose Level 2

Dose Level 3

Treatment at Maximum Tolerated Dose

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Graft Versus Host Disease (GVHD)
Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells
Overall Survival (OS)
The length of time from start of treatment to death by any cause.

Full Information

First Posted
August 16, 2021
Last Updated
July 28, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Florida Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT05015426
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Florida Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Level -1
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
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
Arm Title
Dose Level 3
Arm Type
Experimental
Arm Description
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
Arm Title
Treatment at Maximum Tolerated Dose
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Gamma Delta T-Cell Infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Description
Maximum Tolerated Dose will be determined by testing increasing doses of AAPC-expanded donor γδ T-cells.
Time Frame
Up to 12 months
Title
Dose Expansion: Leukemia Free Survival
Description
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
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Number of Participants with Graft Versus Host Disease (GVHD)
Description
Number of participants with grade II-IV and III-IV acute GVHD within 6 weeks after infusion of Gamma T cells
Time Frame
at 6 weeks
Title
Overall Survival (OS)
Description
The length of time from start of treatment to death by any cause.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelli Bejanyan, MD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Lowden
Phone
813-745-0725
Email
melissa.lowden@moffitt.org
First Name & Middle Initial & Last Name & Degree
Melissa Alsina, MD
First Name & Middle Initial & Last Name & Degree
Hany Elmariah, MD, MS
First Name & Middle Initial & Last Name & Degree
Rawan Faramand, MD
First Name & Middle Initial & Last Name & Degree
Aleksandr Lazaryan, MD, MPH, PhD
First Name & Middle Initial & Last Name & Degree
Hien Liu, MD
First Name & Middle Initial & Last Name & Degree
Frederick Locke, MD
First Name & Middle Initial & Last Name & Degree
Asmita Mishra, MD
First Name & Middle Initial & Last Name & Degree
Taiga Nishihori, MD
First Name & Middle Initial & Last Name & Degree
Jose Ochoa-Bayona, MD
First Name & Middle Initial & Last Name & Degree
Lia Perez, MD
First Name & Middle Initial & Last Name & Degree
Joseph Pidala, MD, PhD
First Name & Middle Initial & Last Name & Degree
Doris Hanen, MD
First Name & Middle Initial & Last Name & Degree
Omar Castaneda Puglianini, MD
First Name & Middle Initial & Last Name & Degree
Ciara Freeman, MD
First Name & Middle Initial & Last Name & Degree
Michael Jain, MD

12. IPD Sharing Statement

Learn more about this trial

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

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