Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06871410

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

Led by Roswell Park Cancer Institute · Updated on 2026-03-24

26

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Karnofsky performance status score 70% or higher
  • Relapsed or refractory AML based on 2022 European Leukemia Net criteria
  • Creatinine clearance of 40 mL/min or higher (Cockroft-Gault)
  • Total bilirubin less than or equal to 2 mg/dL, except for Gilbert's syndrome, hemolysis, or related disease
  • AST and ALT less than 3 times upper limit of normal
  • Left ventricular ejection fraction greater than 45%, no symptomatic congestive heart failure or uncontrolled arrhythmia
  • Oxygen saturation of 92% or higher on room air without need for supplemental oxygen
  • Absolute lymphocyte count at least 0.2 x 10^9/L, hematocrit at least 27%, and platelets at least 20 x 10^9/L; transfusion allowed to meet hematocrit and platelet levels before apheresis
  • Life expectancy of at least 12 weeks from enrollment
  • Negative pregnancy test for females of child-bearing potential
  • If history of allogeneic hematopoietic cell transplant, completed transplant at least 3 months prior, off immunosuppression at least 2 weeks prior to apheresis, no active graft versus host disease requiring treatment
  • Agreement to use adequate contraception prior to study entry and for 12 months after
  • Considered preliminarily eligible for allogeneic hematopoietic cell transplantation with potential donors identified
  • Understand investigational nature and provide informed consent
Not Eligible

You will not qualify if you...

  • Use of systemic glucocorticoids equivalent to more than 10 mg prednisone daily at apheresis or within 4 weeks of CAR T infusion, except for graft versus host disease
  • Diagnosis of acute promyelocytic leukemia (AML M3)
  • Active central nervous system leukemia; history of CNS leukemia in complete response allowed
  • Participation in another investigational therapy protocol within 14 days or 5 half-lives before leukapheresis
  • Need for treatments other than hydroxyurea, single agent cytarabine, hypomethylating agents with or without venetoclax, or targeted agents within 14 days or 5 half-lives before lymphodepletion
  • Ongoing uncontrolled serious infection, pulmonary disease, or psychosocial concerns
  • HIV positive or active hepatitis B or C infection within 4 weeks of enrollment
  • Other active malignancy within 2 years except certain treated skin, cervical, or prostate cancers
  • Active grade II-IV acute graft versus host disease requiring treatment
  • Prior solid organ transplant
  • Active autoimmune disease requiring immunosuppressive therapy
  • Pregnant or nursing females
  • Unwilling or unable to follow protocol requirements
  • Any condition making participant unsuitable for study drug as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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