Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia

Early Phase 1

Recruiting

• Conditions: Acute Myeloid Leukemia Refractory; Acute Myeloid Leukemia Recurrent
• Interventions: Biological: CD123-CAR-NK cells

• Registration Number: NCT05574608
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients.

Detailed Description

This is a study of allogenic CD123-CAR NK cells. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of CD123-CAR-NK cells. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.

Study Timeline

• Study First Submitted: 2022-09-28
• Study Start: 2022-10-01
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1. Central nervous system involved;

2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;

3. Systemic use of hormones within 2 weeks prior to enrollment (except for patients with inhaled corticosteroids);

4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.

5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;

6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;

7. Women who are pregnant (urine/blood pregnancy test positive) or lactating;

8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;

9. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental: Experimental: CD123-CAR-NK.	CD123-CAR-NK cells	The relapsed/refractory AML patients will receive allogenic CD123-Targeted CAR-NK cells infusion (1x10\^9, 1-2x10\^7/kg) after precondition chemotherapy.

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicities (DLTs)	1 Months
Treatment-emergent adverse events	3 months
Treatment-related adverse events	3 months

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	12 months
Complete response (CR)	3 months
Overall Survival (OS)	12 months
Proportion of subjects with minimal-residual disease (MRD) negative response	3 months
The area under the concentration time-curve (AUC) of CD123-CAR-NK cells	3 Months
Peak levels of CD123-CAR-NK cells (maximum concentration or Cmax)	3 Months

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital; 🇨🇳 Beijing, Beijing, China