RecruitingPhase 1NCT06871410

Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial


Sponsor

Roswell Park Cancer Institute

Enrollment

26 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor \[CAR\] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory AML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called CD83 CAR-T cell therapy for people with acute myeloid leukemia (AML) — a cancer of blood-forming cells — that has returned or not responded to standard treatment. **You may be eligible if...** - You are 18 years old or older - You have AML that has relapsed (come back) or is refractory (not responding to treatment) based on current standards - Your heart, kidney, and liver function are within acceptable ranges - Your heart pumping function is above 45% - Your oxygen levels are good without supplemental oxygen - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your AML is in complete remission - You have significant heart failure or uncontrolled heart rhythm problems - You have had a recent stem cell transplant (less than 3 months ago) - You are pregnant or could become pregnant without using reliable contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAutologous Anti-CD83 CAR T-cells

Given IV

PROCEDUREBiospecimen Collection

Undergo bone marrow aspiration blood sample collection

PROCEDUREChest Radiography

Undergo chest x-ray

PROCEDUREComputed Tomography

Undergo CT

DRUGCyclophosphamide

Given IV

PROCEDUREEchocardiography

Undergo ECHO

DRUGFludarabine Phosphate

Given IV

DRUGHydroxyurea

Given hydroxyurea

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDURELumbar Puncture

Undergo lumbar puncture

PROCEDUREPositron Emission Tomography

Undergo PET

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06871410


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