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CD64 CAR T Cell Therapy for Relapsed/Refractory AML

This study is testing a new treatment called CD64 CAR T Cells for adults with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to other treatments (refractory). CD64 CAR T Cells are your own immune cells, specially modified in a lab to find and fight cancer cells. The main goal of this study is to find the safest dose of CD64 CAR T Cells. Researchers will also look at how well these cells expand in your body, how long they last, and if they show early signs of helping to treat AML. You may be able to join if you are 18 or older and have relapsed or refractory AML.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know what treatment you are receiving. It is a dose-escalation study, planning to enroll 23 participants to find the safest dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Maximum Tolerated Dose, is measured from Day 0 through Day 42.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07347418

CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AML

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Colorado, Denver
~23 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:CD64 CAR T Cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Day 0 through Day 42

Conditions

Refractory Acute Myeloid Leukemia (AML)
Relapsed Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome
AML (Acute Myeloid Leukemia)

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Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Mathew Angelos, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Derek Schatz
[email protected]
720-848-0628
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

CD64 CAR T must have met manufacturing criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA)
Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).
Performance status determination (ECOG must be 0, 1 or 2).
Participant remains clinically stable without evidence of vital sign instability including the lack of supportive vasoactive drugs or intensive care support.
Must not have ALT/SGPT and AST/SGOT \> 10x the ULN or total bilirubin \> 3x the ULN, (unless the subject has Gilbert's Syndrome or considered to be due to leukemic involvement)
No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator.

What this trial measures

  • Maximum Tolerated Dose (MTD)Day 0 through Day 42

    MTD will be established from the DLTs, which will be considered from the time of CD64 CAR T infusion (Day 0) through Day 42 after the subject's last infusion. A DLT is a treatment-emergent adverse event, or a clinically significant abnormal laboratory value, observed during the DLT observation period.