Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Terminated; Phase 1

Conditions: AML, Adult

Treatments: Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Cytarabine; Drug: QN-023a

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05601466

IIT2022029

Details and patient eligibility

About

This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).

The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Provision of signed and dated informed consent form (ICF)
• ≥18 years old
• Diagnosis of r/r AML
• Subjects with CD33 positive leukemia cells
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Adequate organ function as defined in the protocol
• Donor specific antibody (DSA) to QN-023a: MFI <= 2000

Key Exclusion Criteria:

• Allergic to drug used in this study
• Accept other anti-tumor drug within certain time of day 0 (first QN-023a dose infusion), time window and drug defined in the protocol.
• received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
• Acute Promyelocytic Leukemia (APL)
• Active central nervous system Leukemia.
• Uncontrolled, active clinically significant infection
• Clinically significant cardiovascular disease as defined in the protocol
• Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
• History of central nervous system (CNS) disease such as stroke, epilepsy.
• Females are pregnant or lactating
• Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

QN-023a

Experimental group

Description:

QN-023a in adult subjects with r/r AML

Treatment:

Drug: QN-023a

Drug: Cytarabine

Drug: Fludarabine

Drug: Cyclophosphamid