Recruiting

Phase 1

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

Sponsor:

University of Kansas Medical Center

Code:

NCT03533816

Conditions

Acute Myeloid Leukemia

Chronic Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndromes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

EAGD T-cell infusion (Phase I)

EAGD T-cell infusion (Expansion)

Study Details

Brief summary:

Gamma delta T-cells are part of the innate immune system with the ability to recognize malignant cells and kill them. This study uses gamma delta T-cells to maximize the anti-tumor response and minimize graft versus host disease (GVHD) in leukemic and myelodysplastic patients who have had a partially mismatched bone marrow transplant (haploidentical).

Conditions

Acute Myeloid Leukemia

Chronic Myeloid Leukemia

Acute Lymphoblastic Leukemia

Myelodysplastic Syndromes

Study ID

NCT03533816

Start date

Jan 31, 2020

Status verified date

Mar, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

The following criteria are used to enroll patients in the study before transplant.

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.

The following criteria are required within 48 hours prior to infusion of the EAGD T cell product.

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 Criteria:

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.

Study Design

Enrollment

38 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EAGD T-cell infusion (Phase I)

Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at either 1, 3, or 10 x 1,000,000 cells/kg concentrations depending upon the cohort.

experimental: EAGD T-cell infusion (Expansion)

Peripheral blood is collected by leukapheresis from the donor, expanded and activated on CliniMACS-Prodigy, further depleted of alpha beta T-cells using the CliniMACS Alpha Beta T-Cell Depletion System, which leaves a gamma delta T-cell rich product. This product is then infused into the recipient at the maximum tolerated dose as determined from Phase I.

Interventions

EAGD T-cell infusion (Phase I)

The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.

EAGD T-cell infusion (Expansion)

The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.

Primary outcome measure

Phase I - Dose-limiting toxicity (DLT) [ Time Frame: Baseline to Day 30 ]
Phase I - Severe acute adverse events following infusion of EAGD T-cells [ Time Frame: Baseline to Day 100 ]
Expansion phase - Rate of acute GVHD [ Time Frame: Baseline to Day 100 ]

Central Contacts and Locations

Central contacts

Clinical Trial Nurse Navigator

913-945-7552 ctnursenav@kumc.edu

Locations

University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Clinical Trials Nurse Navigator

913-945-7552 ctnursenav@kumc.edu

Joseph McGuirk, M.D.

913-588-6030 jmcguirk@kumc.edu

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210-1238

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

Gamma delta T-cells
Hematopoietic Stem Cell Transplantation (HCT)
Post-transplant Cyclophosphamide (PTCy)
Expanded/Activated gamma delta (EAGD)
Graft versus host disease (GVHD)
haploidentical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-03-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.