Cytokine-Induced Memory-Like Natural Killer Cells for Acute Myeloid Leukemia
Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
This study is testing a new way to use special immune cells to help patients with hard-to-treat acute myeloid leukemia feel better when standard chemotherapy isn't an option for them.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT05580601 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 2 years and older with relapsed or refractory AML and available haploidentical related donors.
Not a fit: Patients with isolated central nervous system disease, isolated extramedullary disease, or acute promyelocytic leukemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with relapsed or refractory AML who have limited alternatives.
How similar studies have performed: Other studies have explored similar cellular therapies, showing promise in treating various hematological malignancies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.