Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer

Colorectal Cancer Clinical Trial

Official title:
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

Status Recruiting

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

Clinical Trial Details

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

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.