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Clinical Trial Summary

One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. The purpose of this study is to show that using two medicines (vactosertib and IL-2) with NK cells will be safe and will activate the donor NK cells. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.


Clinical Trial Description

The objective of this research is to demonstrate that natural killer (NK) cells from non-Human Leukocyte Antigen (HLA)-matched donors can be safely infused into colorectal cancer patients and patients with relapsed/refractory hematologic malignancies in combination with IL-2 and the oral transforming growth factor beta (TGFβ) receptor I inhibitor vactosertib to improve the persistence of donor NK cells. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Chronic Lymphocytic Leukemia
  • Chronic Myeloid Leukemia
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Hematologic Malignancy
  • Hematologic Neoplasms
  • Hodgkin Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Lymphoma
  • Multiple Myeloma
  • Myelodysplastic Syndromes
  • Myeloproliferative Syndrome
  • Neoplasms
  • Non Hodgkin Lymphoma
  • Plasma Cell Myeloma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Rectal Neoplasms
  • Rectum Cancer
  • Syndrome

NCT number NCT05400122
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Jennifer Eva Selfridge, MD PhD
Phone 18006412422
Email CTUReferral@UHhospitals.org
Status Recruiting
Phase Phase 1
Start date September 9, 2022
Completion date June 1, 2026

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