Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04024761

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

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

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.

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved CIML NK Cell Infusion as a treatment for relapsed disease.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCIML NKCIML NK cells have enhanced ability to recognize and kill leukemia targets
DRUGFludarabineFludarabine is a chemotherapy agent
DRUGCyclophosphamideCyclophosphamide (CP), also known as cytophosphane among other names, is a chemotherapy agent

Timeline

Start date
2019-08-31
Primary completion
2026-12-01
Completion
2026-12-01
First posted
2019-07-18
Last updated
2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04024761. Inclusion in this directory is not an endorsement.