RecruitingPhase 1NCT04024761

A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation


Sponsor

Dana-Farber Cancer Institute

Enrollment

50 participants

Start Date

Aug 31, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy using specially activated natural killer (NK) cells — a type of immune cell — to treat blood cancers (AML, MDS, or related conditions) that have come back or not gone away after a stem cell transplant from a donor. **You may be eligible if...** - You have AML, MDS (including juvenile MML), or a related bone marrow cancer that has relapsed or persisted after a donor stem cell transplant - Your disease is measurable by bone marrow testing or other methods - You have been off immune-suppressing medications for at least 2 weeks, and it is at least 2 months since your last transplant - Both adult and pediatric patients may be eligible **You may NOT be eligible if...** - You are in severe organ failure or have active, uncontrolled infection - You have active graft-versus-host disease (GVHD) requiring treatment - You are pregnant or breastfeeding - You are currently on high-dose immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCIML NK

CIML NK cells have enhanced ability to recognize and kill leukemia targets

DRUGFludarabine

Fludarabine is a chemotherapy agent

DRUGCyclophosphamide

Cyclophosphamide (CP), also known as cytophosphane among other names, is a chemotherapy agent


Locations(2)

Boston Children's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

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NCT04024761


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