Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06201247

Off-the-shelf CD123 CAR-NK for R/R AML

Led by Peking University People's Hospital · Updated on 2025-03-11

12

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).

CONDITIONS

Official Title

Off-the-shelf CD123 CAR-NK for R/R AML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender or race
  • Expected survival of at least 3 months
  • ECOG performance status score of 0 to 2
  • Diagnosed with AML positive for CD123 by bone marrow biopsy, immunohistochemistry, or flow cytometry
  • Relapsed AML after complete remission with leukemia cells reappearing in blood or bone marrow blast cells ≥5%, extramedullary infiltration, or refractory AML after standard treatments
  • Minimal residual disease positive on bone marrow aspirate by multiparameter flow cytometry
  • Adequate organ function including liver, coagulation, kidney, and heart function within specified limits
  • Women of child-bearing potential and all males must use effective contraception for at least 12 months after infusion
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Active central nervous system leukemia
  • Known contraindication to fludarabine/cyclophosphamide chemotherapy
  • Systemic hormone use within 4 weeks prior to enrollment (except inhaled corticosteroids)
  • Active infection requiring intravenous treatment within 14 days prior to first dose, including HBV, HCV, HIV, syphilis, or active pulmonary tuberculosis
  • History of hypersensitivity to murine protein-containing products or biopharmaceuticals like antibodies or cytokines
  • Inability to guarantee effective contraception for 1 year after enrollment
  • Pregnant or lactating women
  • Serious autoimmune or immunodeficiency diseases
  • Mental illness
  • Known alcohol or drug dependence
  • Other conditions judged by investigator to be unsuitable for participation

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

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

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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