Acute Myeloid Leukemia Clinical Trial

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

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).

View Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT05015426

Recruitment Status:

Recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Rachel Blanton
Contact
813-745-4285
[email protected]
Melissa Alsina, MD
Sub-Investigator
Hany Elmariah, MD, MS
Sub-Investigator
Rawan Faramand, MD
Sub-Investigator
Jeffrey Lancet, MD
Sub-Investigator
Aleksandr Lazaryan, MD, MPH, PhD
Sub-Investigator
Hien Liu, MD
Sub-Investigator
Frederick Locke, MD
Sub-Investigator
Asmita Mishra, MD
Sub-Investigator
Michael Nieder, MD
Sub-Investigator
Taiga Nishihori, MD
Sub-Investigator
Jose Ochoa-Bayona, MD
Sub-Investigator
Lia Perez, MD
Sub-Investigator
Joseph Pidala, MD, PhD
Sub-Investigator
Doris Hanen, MD
Sub-Investigator
Omar Castaneda Puglianini, MD
Sub-Investigator
Ciara Freeman, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT05015426

Recruitment Status:

Recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.