Phase I/II Study of Universal Donor CD33 CAR Natural Killer Cells for Treating Acute Myeloid Leukemia (AML)

Sponsor: Nationwide Children's Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07026942

Provider View

This clinical trial is testing a new treatment for acute myeloid leukemia (AML) that has returned or not responded to other treatments. It uses specially modified immune cells from a healthy donor to target and attack the cancer.

Patient Parameters

Program Overview

The study is exploring a new treatment for AML using modified immune cells called CD33 CAR-NK cells from a healthy donor. These cells are designed to attack cancer cells. The trial has two parts: Phase I will find the safest and most effective dose, and Phase II will test how well the treatment works. Participants will receive chemotherapy followed by the infusion of these modified cells. Some may receive two doses a week apart. Patients will stay in the hospital for monitoring until their blood counts recover. A bone marrow biopsy will be done around day 28-35 to check if the leukemia is in remission. Follow-up will continue for a year, with long-term monitoring for up to 15 years for any side effects.

Description

This study is testing the safety and effectiveness of CD33 CAR-NK cells combined with chemotherapy in patients aged 1-39 with relapsed or hard-to-treat AML. The study has two phases: finding the right dose and then testing its effectiveness. The treatment involves using modified immune cells from a healthy donor to target cancer cells. Participants will receive chemotherapy and then the modified cells. They will stay in the hospital for 4-5 weeks for monitoring. The study will also look at the long-term effects of the treatment, with follow-up for up to 15 years. Some patients may have a bone marrow transplant after the study treatment.

Eligibility Criteria

Inclusion Criteria

  • Patients with relapsed or hard-to-treat AML that shows the CD33 marker.
  • Ages 1 to 39.99 years (first few patients must be 16 or older).
  • Negative pregnancy test for females who can have children.
  • Agree to use effective birth control for 6 months after treatment.
  • Meet specific organ function requirements for kidneys, liver, heart, and lungs.
  • Have a donor ready for a possible bone marrow transplant if needed.
  • Able to understand and sign consent forms.
  • Agree to long-term follow-up for cell and gene therapy.

Exclusion Criteria

  • Recent AML treatments within 14 days before starting the study (except hydroxyurea).
  • Recent treatments with certain drugs or therapies targeting CD33 or the central nervous system.
  • Recent bone marrow transplant within 90 days.
  • On immunosuppressive therapy or have active graft-versus-host disease.
  • Uncontrolled illness or social issues that affect study participation.
  • Breastfeeding or have had a solid organ transplant.
  • Poor performance status (Karnofsky or Lansky score below 50).
  • Uncontrolled infections or heart problems.

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