Clinical Study on the Safety and Efficacy of QN-023a Targeting CD33 in Acute Myeloid Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
The first affiliated hospital of medical college of zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, PhD
hehuangyu@126.com
86-13605714822
Backup
Yongxian Hu, PhD
huyongxian2000@aliyun.com
86-15957162012
Time Frame
Start Date: 2022-12-24
Estimated Completion Date: 2025-12-24
Participants
Target number of participants: 19
Treatments
Experimental: QN-023a
QN-023a in adult subjects with r/r AML
Related Therapeutic Areas
Sponsors
Collaborators: Hangzhou Qihan Biotech Co.,Ltd.
Leads: Zhejiang University