Clinical trial NCT05665114: Natural Killer(NK) Cell Therapy in r/r AML
Official title: Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: AML, Adult
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Hangzhou Qihan Biotech Co.,Ltd.
First posted: 2022-12-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.


Eligibility criteria: Key Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* ≥18 years old
* Diagnosis of r/r AML
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-030a: MFI \<= 2000

Key Exclusion Criteria:

* Allergic to drug used in this study
* Accept other anti-tumor drugs/therapies within certain time of day 0 (first QN-030a 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)
* 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

Primary outcomes:
measure: Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Incidence of dose adjustment or discontinuation due to NK cell toxicities
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
timeFrame: 28 Days from first dose of QN-030a
measure: Determine the Maximum tolerated dose (MTD) and RP2D
timeFrame: 28 Days from first dose of QN-030a
Secondary outcomes:
measure: Overall Response Rate(ORR) of QN-030a in r/r AML
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Relapse-free survival (RFS) of QN-030a in r/r AML
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Time to Response (TTR) of QN-030a in r/r AML
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Event-free survival (EFS) of QN-030a in r/r AML
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Overall Survival (OS) of QN-030a in r/r AML
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Evaluate the immunogenicity features of QN-030a
timeFrame: Up to approximately 2 years after last dose of QN-030a
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital of medical college of zhejiang university
state: Zhejiang
Study officials:
References: