RecruitingEarly Phase 1NCT06201247

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

Safety and 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


Sponsor

Peking University People's Hospital

Enrollment

12 participants

Start Date

Dec 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new type of cell therapy called CAR-NK cells — specially engineered immune cells from a donor — to treat relapsed or treatment-resistant acute myeloid leukemia (AML), a type of blood cancer. The cells target a protein called CD123 found on leukemia cells. **You may be eligible if...** - You have AML that has come back after treatment or has not responded to at least 2 rounds of standard chemotherapy - Your leukemia cells test positive for the CD123 protein - You are 18 or older - Your liver, kidneys, and heart are functioning adequately - You are expected to live at least 3 months - You are willing to use effective contraception for at least 12 months after treatment **You may NOT be eligible if...** - Your leukemia has spread to the brain or spinal fluid - You have an active serious infection (including hepatitis B, hepatitis C, HIV, or tuberculosis) - You have used systemic steroids (by mouth or injection) in the last 4 weeks - You are pregnant or breastfeeding - You have a severe autoimmune disease or immune deficiency - You have a significant mental health condition or substance dependence 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

DRUGJD123 injection

JD123 injection is an universal Off-the-shelf CD123-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) therapy derived from a healthy donor.


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06201247


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