Natural Killer(NK) Cell Therapy in r/r AML
- Conditions
- AML, Adult
- Interventions
- Registration Number
- NCT05665114
- Lead Sponsor
- Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QN-030a VP-16 QN-030a in Adult subjects with r/r AML QN-030a Fludarabine QN-030a in Adult subjects with r/r AML QN-030a QN-030a QN-030a in Adult subjects with r/r AML QN-030a Cyclophosphamid QN-030a in Adult subjects with r/r AML QN-030a Cytarabine QN-030a in Adult subjects with r/r AML
- Primary Outcome Measures
Name Time Method Incidence of subjects with Dose Limiting Toxicities within each dose level cohort 28 Days from first dose of QN-030a Determine the Maximum tolerated dose (MTD) and RP2D 28 Days from first dose of QN-030a Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] Up to approximately 2 years after last dose of QN-030a Incidence of dose adjustment or discontinuation due to NK cell toxicities Up to approximately 2 years after last dose of QN-030a
- Secondary Outcome Measures
Name Time Method Overall Response Rate(ORR) of QN-030a in r/r AML Up to approximately 2 years after last dose of QN-030a Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator.
Time to Response (TTR) of QN-030a in r/r AML Up to approximately 2 years after last dose of QN-030a Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood Up to approximately 2 years after last dose of QN-030a The PK of QN-030a in peripheral blood will be reported as the relative percentage of product (QN-030a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Relapse-free survival (RFS) of QN-030a in r/r AML Up to approximately 2 years after last dose of QN-030a Overall Survival (OS) of QN-030a in r/r AML Up to approximately 2 years after last dose of QN-030a Event-free survival (EFS) of QN-030a in r/r AML Up to approximately 2 years after last dose of QN-030a Evaluate the immunogenicity features of QN-030a Up to approximately 2 years after last dose of QN-030a The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.
Trial Locations
- Locations (1)
The first affiliated hospital of medical college of zhejiang university
🇨🇳Hangzhou, Zhejiang, China