RecruitingPhase 1Phase 2NCT06006403

Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm

Clinical Study of Targeting CD123 Chimeric Antigen Receptor Natural Killer Cells (CAR-NK) in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

36 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed/refractory acute myeloid leukemia (AML) or blastocytic plasmacytoid dendritic cell neoplasm (BPDCN). The pharmacokinetic characteristics of CAR-NK cell preparations for the treatment of patients with Relapsed/refractory acute myeloid leukemia or blastocytic plasmacytoid dendritic cell neoplasm were obtained and the recommended dose.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy — CAR-NK cells (natural killer cells engineered to target a protein called CD123) — in patients with difficult-to-treat blood cancers: acute myeloid leukemia (AML) or a rare condition called BPDCN. **You may be eligible if:** - You are between 18 and 75 years old - Your cancer cells test positive for the CD123 protein - You have AML or BPDCN that has relapsed (come back) or is not responding to standard treatments - You are in reasonably good health and your heart, kidneys, and liver are functioning adequately - Your expected survival is more than 12 weeks **You may NOT be eligible if:** - You have an uncontrolled active infection - You have active hepatitis B or C, or HIV - You are pregnant or nursing - You recently received chemotherapy, radiation, or other cancer treatments (within a specified window) - You have previously received CAR-T or other similar cell therapies (depending on type) 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

BIOLOGICALCD123 targeted CAR-NK cells

Administration method: intravenous infusion; Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.


Locations(1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

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NCT06006403


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