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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: Clinical Trial Phase 1 study, sponsored by Nationwide Children's Hospital.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the safety and recommended phase 2 dose of CD33 CAR-NK cells in patients with relapsed/refractory AML investigators will monitor the incidence and severity of adverse events and the rate of dose limiting toxicities.
Interventions
- BIOLOGICAL Universal donor derived CD33 CAR-NK
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2038-07-01 |
| Phase | Phase 1 |
What is known before NCT07026942 opens enrollment
NCT07026942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Universal donor derived CD33 CAR-NK is the first listed.
NCT07026942 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07026942's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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