Study on Off-the-shelf NK Cells and Stem Cell Transplant for Myeloid Blood Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05115630

Provider View

This clinical trial is exploring the safety and effectiveness of using a new treatment called KDS-1001, which involves special immune cells known as natural killer (NK) cells, combined with a standard stem cell transplant for patients with certain types of blood cancers like acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myeloid leukemia (CML).

Patient Parameters

Program Overview

The purpose of this study is to find out if a new treatment using NK cells from a donor, combined with a stem cell transplant, is safe and effective for patients with specific blood cancers. These NK cells are a type of immune cell that can help fight cancer. The study will look at how well this treatment works, how safe it is, and how it affects patients' health over time.

Description

The main goal of this study is to see if using NK cells from a donor, along with a stem cell transplant, is safe and effective for treating myeloid blood cancers. Researchers will also look at any side effects related to the NK cells, how well the transplant works, and the chances of the cancer returning. They will monitor patients for survival rates, any complications, and infections after the transplant. The study will also assess how well the immune system recovers after treatment.

Eligibility Criteria

Inclusion Criteria

  • Ages 18 to 70 years old.
  • Weigh at least 42 kg (about 93 pounds).
  • Have a specific type of blood cancer (AML, MDS, or CML) and a suitable donor match.
  • For AML: Must have certain high-risk features or have relapsed after previous treatments.
  • For MDS: Must have intermediate or high-risk scores and have not responded to certain therapies.
  • For CML: Must have not responded to or relapsed after treatment with at least two specific drugs, or be in an advanced stage.
  • Have a performance score of at least 70% or 0 to 1 on specific health scales.
  • Have good organ function, including kidney, liver, heart, and lung function.
  • Be able to understand and sign a consent form.
  • Sexually active participants must agree to use effective contraception during the study.

Exclusion Criteria

  • Positive for HIV or active hepatitis B or C.
  • Have uncontrolled infections.
  • Have liver cirrhosis.
  • Have cancer spread to the brain within 3 months before the transplant.
  • Positive pregnancy test in women who can have children.
  • Unable to follow medical instructions or attend follow-up visits.
  • Known allergies to the treatment or its components.
  • Have another active cancer or a cancer in remission for less than 2 years, except for certain skin cancers.
  • Require high doses of steroids.
  • Have specific antibodies against the donor cells.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.