AML, Adult
Conditions
Brief summary
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.
Interventions
DRUGQN-023a
NK cell therapy
DRUGCyclophosphamid
Lympho-conditioning Agent
DRUGFludarabine
Lympho-conditioning Agent
DRUGCytarabine
Lympho-conditioning Agent
Sponsors
Hangzhou Qihan Biotech Co.,Ltd.
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 28 Days from first dose of QN-023a |
| The incidence of subjects with Dose Limiting Toxicities within each dose level cohort | 28 Days from first dose of QN-023a |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate(ORR) | Up to approximately 2 years after last dose of QN-023a | — |
| Relapse-free survival (RFS) of participants | Up to approximately 2 years after last dose of QN-023a | — |
| Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood | Up to approximately 2 years after last dose of QN-023a | The PK of QN-023a in peripheral blood will be reported as the relative percentage of product (QN-023a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points |
Countries
China
Outcome results
None listed