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 19 patients will be enrolled.
Interventions
Sponsors
Hangzhou Qihan Biotech Co.,Ltd.
Zhejiang University
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 drugs/therapies 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) * 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 and severity of Treatment-Emergent Adverse Events[Safety and Tolerability] | Up to approximately 2 years after last dose of QN-023a |
| Incidence of dose adjustment or discontinuation due to NK cell toxicities | Up to approximately 2 years after last dose of QN-023a |
| Incidence of subjects with Dose Limiting Toxicities within each dose level cohort | 28 Days from first dose of QN-023a |
| Determine the maximum tolerated dose (MTD) and RP2D | 28 Days from first dose of QN-023a |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate(ORR) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a | Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator. |
| Relapse-free survival (RFS) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a | — |
| Evaluate the immunogenicity features of QN-023a | Up to approximately 2 years after last dose of QN-023a | The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured. |
| 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 |
| Time to Response (TTR) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a | — |
| Event-free survival (EFS) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a | — |
| Overall Survival (OS) of QN-023a in r/r AML | Up to approximately 2 years after last dose of QN-023a | — |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Backup ContactYongxian Hu, PhD
Outcome results
None listed