Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05945849

CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML

Led by University of Pennsylvania · Updated on 2025-06-29

16

Participants Needed

1

Research Sites

1043 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to provide a new type of treatment for AML. This treatment combines a new type of stem cell transplant along with treatment using chimeric antigen receptor (CAR) T cells that have been engineered to recognize and attack your AML cells. The first treatment is a modified stem cell transplant, using blood-forming stem cells donated from a healthy donor. From the same donor, we will also make CAR T-cells, which are leukemia fighting cells, which will be given to the patient via an infusion into the vein after the transplanted stem cells have started to grow healthy blood cells. The modification of the stem cell transplant means that the healthy bone marrow cells will be "invisible" to the CAR T-cells that are trying to kill the leukemia cells.

CONDITIONS

Official Title

CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 18 years of age or older
  • Diagnosed with AML unlikely to be cured by current therapies
  • AML not in complete remission or with refractory disease, or relapsed after stem cell transplant
  • If relapsed after prior transplant, off systemic immunosuppression for at least 1 month
  • Have a suitable stem cell donor
  • Creatinine clearance greater than 40 ml/min
  • ALT/AST liver enzymes 5 times or less the upper limit of normal unless disease related; if disease related less than 20 times upper limit
  • Direct bilirubin less than 2.0 mg/dl unless Gilbert's syndrome (less than or equal to 3.0 mg/dL)
  • Left ventricular ejection fraction 40% or higher
  • DLCO greater than 45% predicted
  • ECOG performance status 0-1
  • Provide written informed consent
  • Use acceptable birth control if of reproductive potential
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Active hepatitis B, hepatitis C, or HIV infection
  • Concurrent use of systemic steroids or immunosuppressants
  • Any uncontrolled active medical disorder preventing participation
  • Signs or symptoms of central nervous system involvement
  • Known allergy to study product ingredients (human serum albumin, DMSO, Dextran 40)
  • Class III or IV heart disability per New York Heart Association
  • History of optic neuritis or other immune or inflammatory diseases of the central nervous system unrelated to leukemia
  • Clinically apparent or unstable arrhythmias within 2 weeks of screening or enrollment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

A

Abramson Cancer Center Clinical Trials Service

CONTACT

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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