Clinical trial NCT05015426: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: AML
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2021-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: Up to 12 months
measure: Dose Expansion: Leukemia Free Survival
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of Participants with Graft Versus Host Disease (GVHD)
timeFrame: at 6 weeks
measure: Overall Survival (OS)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nelli Bejanyan, MD
role: PRINCIPAL_INVESTIGATOR
References: