Clinical trial · Interventional
Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease
Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia With Minimal Residual Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It did not reach the expected results of clinical trial
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Minimal Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamid | Drug | — | UNRESOLVED |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| QN-030a | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QN-030a
- description
- QN-030a in Adult subjects with MRD
- interventionNames
- Drug: QN-030a
- Drug: Cyclophosphamid
- Drug: Fludarabine
- Drug: Cytarabine
Primary outcomes (2)
- 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 (4)
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 * 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
References
Publications (0)
Data not yet available