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

Recruiting now · Phase 1

Conditions studied: Acute Myeloid Leukemia, Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes

In brief

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).

Key facts

Study ID

NCT03533816

Run by

University of Kansas Medical Center

People needed

38

Starts

2020-01-31

Expected to finish

2028-01-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• Ohio State University Medical Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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