Clinical trial · Interventional
Natural Killer (NK) Cell Therapy Targeting CD33 in Acute Myeloid Leukemia
Clinical Study on the Safety and Efficacy of QN-023a Targeting CD33 in Acute Myeloid Leukemia
NCT05665075CI-TRIAL-00062973unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML, Adult | Adult Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamid | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| QN-023a | Drug | — | UNRESOLVED |
| VP-16 | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QN-023a
- description
- QN-023a in adult subjects with r/r AML
- interventionNames
- Drug: QN-023a
- Drug: Cyclophosphamid
- Drug: Fludarabine
- Drug: Cytarabine
- Drug: VP-16
Primary outcomes (4)
- measure
- Incidence and severity of Treatment-Emergent Adverse Events[Safety and Tolerability]
- timeFrame
- Up to approximately 2 years after last dose of QN-023a
- measure
- Incidence of dose adjustment or discontinuation due to NK cell toxicities
- timeFrame
- Up to approximately 2 years after last dose of QN-023a
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.