NCT06138587

Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation

Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: * CIML NK cells intravenous infusion (cellular therapy) * Subcutaneous Interleukin-2 (recombinant, human glycoprotein)

Detailed description

This is a phase I/Ib study of the pre-emptive treatment using related donor-derived cytokine induced memory-like (CIML) natural killer (NK) cells combined with Interleukin-2 (IL-2) for participants with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and MDS/myeloproliferative neoplasm (MDS/MPN) overlap syndrome at high risk for post-allogeneic stem cell transplant (SCT) relapse. The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as a treatment for AML, MDS or MDS and MPN overlap syndrome. The research study procedures include screening for eligibility, intravenous infusion of CIML NK cells in the hospital, standard-of-care stem cell infusion, subcutaneous interleukin-2 (IL-2) infusions, x-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, bone marrow biopsies, echocardiograms, and electrocardiograms. Participation in this research study is expected to last up to 3 years. It is expected that up to 30 people will take part in this research study.

Conditions

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Myelodysplastic Syndromes
• Myeloproliferative Neoplasm
• Myeloproliferative Disorders

Interventions

Type	Name	Description
BIOLOGICAL	Cytokine Induced Memory-like Natural Killer Cells	Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
BIOLOGICAL	Interleukin-2	Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous injection per protocol.

Timeline

• Start date: 2024-01-24
• Primary completion: 2027-02-28
• Completion: 2027-11-30
• First posted: 2023-11-18
• Last updated: 2026-01-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study