Safety and Efficacy of Expanded, Universal Donor Natural Killer Cells for Relapsed/Refractory AML (NCT05503134)
๐ฉบ Plain-English Summary (8th-Grade Level)
This is a phase I/II dose escalation study designed to determine the safety and estimate the efficacy of UD-NK cells combined with FLA chemotherapy in patients age 1-24.99 with relapsed or refractory acute myeloid leukemia. PRIMARY OBJECTIVE: I. To determine the safety and recommended phase II dose of adoptive NK cell therapy using UD-NK cells in pediatric and young adult patients with relapsed/refractory AML. SECONDARY OBJECTIVES: I. To estimate the efficacy of UD- NK cells with FLA chemotherapy in pediatric and young adult patients with relapsed/refractory AML. EXPLORATORY OBJECTIVES: I. To determine the immunophenotype and function of UD-NK cells II. To characterize in vivo expansion of UD-NK cells III. To determine the persistence of UD-NK cells Six doses of universal donor mbIL-21 expanded NK cells (UD-NK) given thrice weekly for two weeks. Days may vary and NK cells can be given from days 0 to 21. Patients may receive up to 2 cycles of fludarabine/cytarabine (FLA) + NK cells (up to 12 NK cell infusions) if they do not achieve CR after cycle 1 or if necessary to bridge to transplant.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (12 items).
Location: Nationwide Children's Hospital โ Columbus, Ohio
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- AML directed therapies in the 2 weeks prior to beginning treatment on this protocol (except for hydroxyurea) o Note: There is no waiting period required for patients having received intrathecal cytarabine, methotrexate and/or hydrocortisone
- Patients on immunosuppressive therapy o Patients must be off of all systemic immunosuppressive therapy for at least 2 weeks prior to enrollment with no evidence of recurrent GVHD
- Patients with a history of donor lymphocyte infusion or cellular therapy within the last 30 days are not eligible for this study
- Allogeneic SCT \< 3 months prior to study enrollment
- Any comorbidities that in the opinion of the investigator will preclude receiving study therapy
- Performance status: Karnofsky or Lansky Performance Scale (PS) \< 50
- Uncontrolled infection, defined as an infection which has not resolved or does not show evidence of significant resolution after initiating appropriate therapy o Asymptomatic viremia such as CMV, HPV, BK virus, HCV, etc. is NOT considered as an exclusion criterion
- Uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease
- History of autoimmune disease
- Active GVHD at the time of enrollment
- Patients with a history of adoptive cell therapy are excluded unless at least 30 days from infusion and with evidence of recovery of normal hematopoiesis (ANC โฅ 500/ฮผL, platelet count โฅ 50,000/ฮผL).
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Nationwide Children's Hospital โ Columbus, Ohio
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.