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EAGD T-cell Infusion After Stem Cell Transplant for Blood Cancers

This study is testing a new approach for people with certain blood cancers, like leukemia and myelodysplastic syndromes, who are receiving a stem cell transplant from a partially matched family member. The study uses a special type of immune cell called Expanded/Activated Gamma Delta (EAGD) T-cells (EAGD T-cell infusion). These cells are known to fight cancer without causing severe graft-versus-host disease (GVHD), a common complication after transplants. The goal is to see if EAGD T-cells can help kill cancer cells while minimizing GVHD. Researchers will be looking at how safe the EAGD T-cell infusion is and how often GVHD occurs. You can join if you are 18-65 years old and have one of the specified blood cancers needing a transplant.

Study design
This is an interventional study with a planned enrollment of 38 participants. It includes a Phase I to assess safety and an expansion phase to evaluate the rate of acute GVHD.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored up to 100 days after the infusion, and the rate of acute GVHD will be evaluated up to 100 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03533816

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

Recruiting
PHASE1Ages 18–65InterventionalTreatment
University of Kansas Medical Center
~38 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:EAGD T-cell infusion (Phase I)EAGD T-cell infusion (Expansion)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I - Dose-limiting toxicity (DLT)
Measured over Baseline to Day 30
+2 more outcomes measured

Conditions

Acute Myeloid Leukemia
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes

Explore related trials

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveMyelodysplastic Syndrome

Where it's being run

2 sites across 2 states
Kansas1
Ohio1

Study leadership

  • Joseph McGuirk, M.D. · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Clinical Trial Nurse Navigator
[email protected]
913-945-7552
Email the study team

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Eligibility criteria

Inclusion

Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:
Acute myeloid leukemia \[AML\] in morphologic complete remission with intermediate/high-risk features (per NCCN criteria) or relapsed disease
Chronic myeloid leukemia \[CML\] in any chronic phase.
Myelodysplastic syndrome \[MDS\] with intermediate/high risk features or refractory disease (with bone marrow blast count \<10%).
Acute lymphoblastic leukemia \[ALL\] in morphologic complete remission with high-risk features or relapsed disease.
Negative test for donor-specific antibody within 28 days of starting conditioning regimen.
Age Criteria: 19-65 years.
Organ Function Criteria: The following organ function testing should be done within 35 days before study registration.
Cardiac: Normal left ventricular ejection fraction (LVEF) (50% or above) as measured by MUGA or Echocardiogram.
Pulmonary: FVC, FEV1 and DLCO (corrected) should be 50% or above of expected.
Renal: serum creatinine level to be \<2 mg/dl AND estimated (Cockcroft-Gault formula) or measured (takes priority if done) creatinine clearance (CrCl) must be equal or greater than 70 mL/min/1.73 m2.
Hepatic: serum bilirubin 1.5 upper limit of normal (ULN), Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN, and alkaline phosphatase 2.5 ULN.
Performance status: Karnofsky performance score (KPS) or Lansky score: ≥80.
Hematopoietic cell transplant comorbidity index (HCT-CI) \<3. Exception may be made on individual cases after discussion with the primary investigator.
Consent: All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Absence of uncontrolled infection with sepsis syndrome (e.g persistent positive blood culture).
NO hemodynamic instability (due to sepsis or organ dysfunction) or circulatory volume overload.
NO clinically significant organ toxicity that are defined as follows:
Heart failure with subnormal LVEF or clinical fluid overload.
Elevated serum creatinine or subnormal creatinine clearance (either estimated or measured).
Elevated total bilirubin ≥1.5 upper normal level (unless indirect hyperbilirubinemia attributed to non-hepatic pathology), or elevated liver enzymes (ALT, AST, ALP) \>5 x ULN.
Hypoxemia requiring oxygen therapy
NO acute graft versus host disease (any grade).
Neutrophil engraftment.

Exclusion

Non-compliant patients.
No appropriate caregivers identified.
Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
Active central nervous system (CNS) neoplastic involvement.
Morbid obesity with body mass index \>35 (borderline cases may be considered on case-by-case basis after discussion with the primary investigator).
Patients with known allergy to DMSO.
HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive.
Pregnant or breastfeeding women.

What this trial measures

  • Phase I - Dose-limiting toxicity (DLT)Baseline to Day 30

    The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.

  • Phase I - Severe acute adverse events following infusion of EAGD T-cellsBaseline to Day 100

    Safety of the infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.

  • Expansion phase - Rate of acute GVHDBaseline to Day 100

    Monitoring for GVHD is assessed with Grade II-IV adverse events as identified by the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 4.