NK Cells Plus Vactosertib

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

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
12
Last Updated
2 months ago
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Participating Centers

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Experimental Treatments

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  • Vactosertib is a small molecule TGF-β type I receptor kinase inhibitor.
  • Fludarabine is a chemotherapy agent used in the treatment of cancer.
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Natural Killer (NK) Cells can work in cancer treatment by being modified to recognize and attack tumor cells in the body. Natural Killer Cells are already found in the body, and are unique because they are able to recognize and attack cells without being acted upon by an antigen (immunization).
  • Interleukin-2 is an immunotherapy drug used to treat several different indications. It works to help certain parts of your immune system to increase production of immune cells.

Arms / Cohorts

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Accepting patients

Experimental Infusion

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