Actively Recruiting

Phase 1
Phase 2
Age: 6Years - 90Years
All Genders
NCT06420063

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

Led by Essen Biotech · Updated on 2024-11-12

85

Participants Needed

1

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.

CONDITIONS

Official Title

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

Who Can Participate

Age: 6Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with acute myeloid leukemia and voluntarily signed informed consent
  • Age older than 6 months
  • Confirmed expression of CLL-1, CD123, and/or CD33 on AML blast cells
  • Karnofsky performance status score higher than 80 and life expectancy greater than 3 months
  • Adequate bone marrow, liver, and kidney function as shown by lab tests
  • Cardiac ejection fraction of 50% or higher
  • Oxygen saturation of 90% or higher
  • Creatinine no more than 2.5 times the upper limit of normal
  • AST and ALT no more than 3 times the upper limit of normal
  • Total bilirubin no more than 2.0 mg/dL
  • Hemoglobin level of 80 g/L or higher
  • No contraindications for cell separation
  • Ability and willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Severe illness or medical condition preventing study management, including uncontrolled infection
  • Active bacterial, fungal, or viral infection not controlled by treatment
  • Known infection with HIV, hepatitis B virus, or hepatitis C virus
  • Pregnant or nursing women
  • Use of systemic glucocorticoids within one week before joining the trial
  • Inability to comply with study requirements as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

District One Hospital

Beijing, Beijing Municipality, China, 086-373

Actively Recruiting

Loading map...

Research Team

R

Rhoda M Smith, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here