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Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN

Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/refractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)

NCT06690827•Chongqing Precision Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.

Detailed Description

This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of antiCD123 CAR-NK therapy for the treatment of patients with relapsed/refractory AML or BPDCN. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×107 CAR-positive cells/kg, 3×107 CAR-positive cells/kg, and 5×107 CAR-positive cells/kg. Each patient will receive two infusions of CAR-NK cells on D0 and D7, respectively, with the doses for both infusions principally remaining the same. However, the investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients of any gender, aged between 18 and 75 years (inclusive);
•2. Positive expression of CD123 on tumor cells detected by flow cytometry;
•3. Patients with a confirmed diagnosis of CD123-positive relapsed/refractory AML or BPDCN:
•(1) For AML patients：
•Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemic cell infiltration outside the marrow;
•Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation/intensification therapy; patients who have relapsed after 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;
•(2) For BPDCN patients: Patients who have not responded to or cannot tolerate the recommended salvage treatment according to guidelines, and have persistent or recurrent disease in any of the following: peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other sites.
•4\. Expected survival time of more than 12 weeks;
•5\. ECOG score of 0-2 (Appendix 2);
•6\. No severe mental disorders;
+8 more criteria

Exclusion Criteria

•1. Presence of active central nervous system invasion during screening;
•2. Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter), except for those who have confirmed disease progression after treatment;
•3. Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;
•4. Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;
•5. Presence of any of the following cardiac diseases:
•1. Congestive heart failure at New York Heart Association (NYHA) class III or IV;
•2. Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;
•3. Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding cases caused by vasovagal or dehydration);
•4. History of severe non-ischemic cardiomyopathy;
•6. Combination with active autoimmune diseases requiring long-term immunosuppressive therapy;
+4 more criteria

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

Wuhan, Hubei, China

Key Dates

Start Date

November 13, 2024

Primary Completion Date

October 30, 2027

Completion Date

October 30, 2028

Last Updated

November 15, 2024

Enrollment

ESTIMATED participants

Conditions

AML (Acute Myeloid Leukemia)BPDCN (blastic Plasmacytoid Dendritic Cell Neoplasm)

Interventions

Anti-CD123 CAR NK cells

DRUG

Contacts

Wei Jia, Professor

CONTACT

+86 13986102084 jiawei@tjh.tjmu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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