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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

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

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

NCT ID

NCT05015426

First Posted

August 16, 2021

Last Updated

July 28, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Florida Department of Health

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

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

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

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

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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