NK cell therapy for relapsed acute myeloid leukemia
Clinical Study on the Safety and Efficacy of QN-023a Targeting CD33 in Acute Myeloid Leukemia
PHASE1 · Zhejiang University · NCT05665075
This study is testing a new type of immune cell therapy to see if it can help people with relapsed acute myeloid leukemia feel better and improve their treatment outcomes.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05665075 on ClinicalTrials.gov |
What this trial studies
This open-label, Phase I study evaluates the safety, tolerability, and preliminary efficacy of QN-023a, an allogeneic CAR-NK cell therapy targeting CD33, in patients with relapsed or refractory Acute Myeloid Leukemia (AML). The study will utilize a '3+3' enrollment schema during the dose escalation phase, aiming to enroll up to 19 patients. Participants will receive QN-023a along with other chemotherapy agents such as Cyclophosphamide, Fludarabine, Cytarabine, and VP-16.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with relapsed/refractory AML and CD33 positive leukemia cells.
Not a fit: Patients with acute promyelocytic leukemia, central nervous system leukemia, or those with uncontrolled infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed or refractory AML.
How similar studies have performed: While this approach is innovative, similar studies targeting CD33 in AML have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: He Huang, PhD
- Email: hehuangyu@126.com
- Phone: 86-13605714822
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AML, Adult