Cytokine-Induced Memory-Like Natural Killer Cells for Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to generate cytokine-induced memory-like natural killer (NK) cells from donor cells and safely infuse them into patients with relapsed or refractory acute myeloid leukemia (AML). Patients who are unlikely to benefit from standard chemotherapy will receive a lymphodepleting chemotherapy regimen followed by the infusion of these CIML-NK cells. The primary focus is on the feasibility and safety of this infusion, while secondary objectives include assessing the clinical response and the persistence of the NK cells in the bloodstream. The study targets patients who do not qualify for or wish to participate in traditional chemotherapy trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Zahra Hudda — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Zahra Hudda
• Email: Zahra.Hudda@cchmc.org
• Phone: 917-754-7118

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Characterization of CD180 Protein Expression in Myeloid Blood C cancers

  This study tests how CD180 is presented on myeloid cancer cells and normal stem cells using existing patient samples from AML cases to see if it could help with diagnosis or monitoring.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07895901

• Personalized AML: Find biomarkers to predict response to venetoclax

  This study tests whether single-cell analyses can help group AML patients by biology and find biomarkers that predict who will respond to venetoclax.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07874100

• Low-dose Liposomal Amphotericin B for preventing fungal infections in adults with blood cancers and prolonged neutropenia

  This study tests whether giving a daily 50 mg dose of liposomal amphotericin B can help prevent invasive fungal infections in adults with blood cancers who have prolonged low white blood cell counts.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Hainan, Hainan · NCT07763054

• MAX-40279 with Venetoclax and Azacitidine for unfit newly diagnosed AML

  This study tests MAX-40279 added to venetoclax and azacitidine in older or unfit adults newly diagnosed with AML to see if it is safe and shows activity.

  Recruiting Phase 2 Maxinovel Pty., Ltd. · Tianjin · NCT07743112

• Venetoclax and Azacitidine Consolidation After Remission in Intermediate-Risk AML

  We’re testing if a venetoclax-plus-azacitidine consolidation approach works as well as standard high-dose chemotherapy for adults with intermediate-risk AML who have already achieved remission and are headed to stem cell transplant.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07672262

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.