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NCT07026942 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Clinical Trial of Universal Donor CD33 CAR Natural Killer Cells for AML

A Phase 1 study, sponsored by Nationwide Children's Hospital.

Not yet
Registry status
Phase 1
Development phase
42
Enrollment target

NCT07026942 is a Phase 1 study that has not yet begun recruiting, run by Nationwide Children's Hospital. The registered enrollment target is 42 participants.

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The verdict

NCT07026942, a Phase 1 study, has not yet begun recruiting, sponsored by Nationwide Children's Hospital.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
42 participants
Enrollment target

Study Summary

This phase 1/2 study is testing a new treatment for acute myeloid leukemia (AML) that has come back or has not responded to other treatments. The treatment uses specially modified immune cells (called CD33 CAR-NK cells) from a healthy, unrelated donor to attack the cancer. The first part of the study (Phase I) will focus on finding the safest and most effective dose. The second part (Phase II) will test how well the treatment works at that dose. Patients will undergo screening, chemotherapy (Fludarabine and Cytarabine, in combination with Venetoclax) followed by the infusion of the CD33 CAR NK cells. Some patients may receive 2 doses of CD33 CAR NK cells infused 1 week apart. The investigator will let participants know if they will receive 1 or 2 doses. Patients will be hospitalized for the chemotherapy and CD33 CAR NK cell infusion for close monitoring and will remain in the hospital until blood counts recover. If patients are discharged from the hospital before day 35, they will be followed in clinic weekly for blood work and a physical exam. A bone marrow biopsy will be performed around day 28-35 to see if the patient's leukemia is in remission. Lumbar puncture or imaging may also be done if the study doctor thinks it is necessary. Patients will continue to be followed for research studies and clinical outcomes (leukemia relapse, survival) for 1 year. After 1 year, patients will have completed their study participation, but can be monitored for up to 15 years for potential long term side effects of the cell therapy. Some patients may undergo a bone marrow transplant after the study treatment. Patients who proceed to bone marrow transplant will have one blood sample drawn about a month after the transplant and then will have completed study participation.

Interventions

  • BIOLOGICAL Universal donor derived CD33 CAR-NK

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2026-04-01
Est. Completion 2038-07-01
Phase Phase 1

Sponsor

Nationwide Children's Hospital

188 total trials

What the Registry Record Tells You About NCT07026942

The ClinicalTrials.gov registry entry for NCT07026942 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Universal donor derived CD33 CAR-NK is the first listed.

NCT07026942 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT07026942 about?

NCT07026942 is a clinical study titled "Phase I/II Clinical Trial of Universal Donor CD33 CAR Natural Killer Cells for AML". This phase 1/2 study is testing a new treatment for acute myeloid leukemia (AML) that has come back or has not responded to other treatments. The treatment uses specially modified immune cells (called CD33 CAR-NK cells) from a healthy, unrelated donor to attack the cancer. The first part of the stu...

What is the current status of trial NCT07026942?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2026-04-01. Estimated completion is 2038-07-01.

What interventions are being tested in trial NCT07026942?

The interventions under investigation include: Universal donor derived CD33 CAR-NK (BIOLOGICAL).

Who is sponsoring clinical trial NCT07026942?

This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.