Donor immune cells take on tough leukemia in early trial
NCT ID NCT05580601
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether specially trained immune cells from a half-matched donor can safely treat acute myeloid leukemia (AML) that has come back or not responded to standard treatment. About 20 people aged 2 and older will receive an infusion of these cells. The main goal is to see if the infusion is safe, and the researchers will also check if it helps control the leukemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cytokine-Induced Memory-Like Natural Killer (CIML-NK) cells from a half-matched donor
- What this could lead to
- If it works, this could point toward a new treatment option for hard-to-treat AML using the body's own immune cells.
- What could go wrong
- This is an early Phase 1/2 trial with only 20 people, so it is too small to prove effectiveness. There are risks of infusion reactions or the cells not lasting long enough.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
2 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Of age ≥ 2 years of age at the time of study enrollment * With AML diagnosed per 2016 WHO criteria (11) * With relapsed or refractory AML in their bone marrow * Refractory disease: Patients must have ≥ 5% blasts in the bone marrow after 2 courses of intensive induction treatment * Relapsed disease: Patients must have ≥ 5% blasts in the bone marrow, or reappearance of blasts in the blood, within 6 months of initial CR * With available haploidentical related donors. Donor specific antibody (DSA) testing will be done on the recipient prior to or upon enrollment. * With performance level of ≥ 50% on Karnofsky scale for patients \> 16 years of age and ≥ 50% on Lansky scale for patients ≤ 16 years of age Exclusion Criteria: * Disease: isolated central nervous system (CNS) disease, or isolated extramedullary disease, or diagnosis of acute promyelocytic leukemia (APML). Patients with extramedullary disease in combination with bone marrow disease are eligible for enrollment. * Infectious Disease: Active uncontrolled infection * Cardiac function: Systolic ejection fraction \<45% by echocardiogram * Pulmonary Function: Oxygen saturation \<92% on room air * Hepatic function: Total bilirubin \> 2mg/dL, AST and ALT more than three times the upper limit of normal * Concomitant medications: receiving either \>10mg prednisone equivalent daily, or \>0.5mg/kg prednisone equivalent daily, whichever is less * Concomitant investigational treatments: receiving other investigational therapies * Known allergy or hypersensitivity reaction to IL-2 injections * Pregnant or breastfeeding women will not be entered on this study due to risks of fetal and teratogenic adverse events with lymphodepleting chemotherapy. Pregnancy tests must be obtained for female patients. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion. Effective contraceptive methods include oral contraceptive pills, patches, or injections, intrauterine devices, having a tubal ligation, having a partner who has had a vasectomy, or not having sex.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Cincinnati Children's Hospital Medical Center
RECRUITINGCincinnati, Ohio, 45229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a p53-Targeting drug boost chemotherapy in Hard-to-Treat 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?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?