Study on Using Genetically Modified Cord Blood-Derived NK Cells with Chemotherapy for Treating Relapsed or Hard-to-Treat Blood Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT05110742

Provider View

This clinical trial is testing a new treatment using genetically modified natural killer (NK) cells from cord blood, combined with chemotherapy, to treat patients with certain blood cancers that have returned or are difficult to treat. The study aims to find the safest and most effective dose for each type of cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment using genetically engineered NK cells from cord blood, combined with chemotherapy, for patients with relapsed or hard-to-treat blood cancers like T-cell malignancies, mantle cell lymphoma, and chronic lymphocytic leukemia. Researchers aim to determine the best dose for each specific type of cancer.

Description

This study is focused on testing a new treatment approach for certain blood cancers that have returned or are difficult to treat. The treatment involves using NK cells, which are a type of immune cell, that have been genetically modified to better target cancer cells. These NK cells are derived from cord blood and are combined with chemotherapy to enhance their effectiveness.

The main goal of the study is to ensure that this treatment is safe and to find the most effective dose for each type of cancer being studied. Researchers will also look at how well the treatment works in terms of reducing cancer size or eliminating it completely, and how long the modified NK cells remain active in the body.

Participants will undergo a series of tests and evaluations to ensure they meet the study criteria. The treatment process involves receiving the modified NK cells along with chemotherapy, followed by regular monitoring to assess the treatment's impact and any side effects.

Eligibility Criteria

Exclusion Criteria

  • Women who are pregnant or breastfeeding, or who could become pregnant and have not gone through menopause or had surgical sterilization.
  • Have severe side effects from previous treatments that are not resolved.
  • Have uncontrolled infections that are not responding to treatment.
  • Have active hepatitis B or C infections.
  • Have HIV with a detectable viral load.
  • Have active neurological disorders.
  • Have an active autoimmune disease within the past year.
  • Have cancer affecting the brain or spinal cord.
  • Have active graft-versus-host disease (GVHD) requiring treatment.
  • Have another active cancer, except for certain treated skin or cervical cancers.
  • Have any other serious medical condition that could pose a risk.
  • Have had major surgery within the past four weeks.
  • Have had a stem cell transplant or donor lymphocyte infusion within the past 12 weeks.
  • Are using other investigational or anti-cancer drugs.
  • Are receiving systemic steroid therapy, except for replacement doses, or have recently received certain immunosuppressive treatments.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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