Supercharged immune cells may make bone marrow transplants safer and more effective
NCT ID NCT03533816
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether giving patients extra gamma delta T-cells—a type of immune cell that can kill cancer—after a half-matched bone marrow transplant can improve outcomes. The study includes up to 38 adults with leukemia or myelodysplastic syndromes. The goal is to see if this approach is safe and helps prevent cancer relapse while reducing graft-versus-host disease, a common and serious transplant complication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gamma delta T-cells (a type of immune cell grown in the lab)
- What this could lead to
- If it works, this could improve the success of half-matched bone marrow transplants by helping the new immune system attack cancer cells while reducing harmful side effects.
- What could go wrong
- This is an early phase 1 trial with only 38 participants, so safety and effectiveness are not yet proven. There is a risk of severe side effects, including graft-versus-host disease or organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2020
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ohio State University Medical Center
RECRUITINGColumbus, Ohio, 43210-1238, United States
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University of Kansas Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding venetoclax make donor stem cell transplants safer for High-Risk blood cancers?
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- New drug takes aim at Treatment-Resistant leukemia
- Engineered immune cells aim to wipe out stubborn leukemia
- Two-Drug combo targets leukemia that outsmarted its first treatment