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NK cells in combination with IL-2 and TGFbeta Receptor I inhibitor vactosertib in cancer

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A Phase Ib study to evaluate safety and persistence of ex vivo expanded universal donor NK cells in combination with IL-2 and TGFbeta Receptor I inhibitor vactosertib in patients with locally advanced/metastatic colorectal cancer and relapsed/refractory hematologic malignancies

  • Sex at Birth: Any
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: Phase I
  • Conditions Being Studied: Cancer - Colorectal, Cancer - Hodgkin Lymphoma, Cancer - Leukemia, Cancer - Non-Hodgkin Lymphoma

Study Purpose

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.

Principal Investigator
Jennifer Selfridge MD PhD
Department/Division
Cancer (Any Solid Tumor)

Locations

UH Seidman Cancer Center
11100 Euclid Avenue
Cleveland OH, 44106

  • UH IRB: STUDY20220405
  • StudyID: CASE6Y21
  • ClinicalTrials.gov: NCT05400122
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