Clinical trial NCT05601830: Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease
Official title: Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia With Minimal Residual Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Minimal Residual Disease
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 1
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 Acute Myeloid Leukemia Minimal Residual Disease(AML MRD).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-020a in patients with AML MRD, 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
* Subject diagnosed of AML MRD.
* 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 drug within 2 weeks of day 0 (first QN-030a dose infusion)
* Prior allogeneic hematopoietic stem cell transplant (HSCT) within 6 months of Day 0, 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
* History of central nervous system (CNS) disease such as stroke, epilepsy.
* Females are pregnant or lactating
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* 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 of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 28 Days from first 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
Secondary outcomes:
measure: Number of participants achieving MRD-
timeFrame: 28 Days from first dose of QN-030a
measure: Relapse-free survival (RFS) of participants
timeFrame: Up to approximately 2 years after last dose of QN-030a
measure: Overall survival (OS) of participants
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
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References: