Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05601466
Other study ID # QN023aTXM1
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 28, 2022
Est. completion date October 21, 2025

Study information

Verified date November 2022
Source Institute of Hematology & Blood Diseases Hospital
Contact Jianxiang Wang
Phone 022-23909120
Email wangjx@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 18 patients will be enrolled.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date October 21, 2025
Est. primary completion date October 21, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 drug 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) - Active 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
QN-023a
NK cell therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
Cytarabine
Lympho-conditioning Agent

Locations

Country Name City State
China Institute of Hematology & Blood Diseases Hospital Tianjin Tianjin

Sponsors (2)

Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital Hangzhou Qihan Biotech Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 28 Days from first dose of QN-023a
Primary The incidence of subjects with Dose Limiting Toxicities within each dose level cohort 28 Days from first dose of QN-023a
Secondary Overall Response Rate(ORR) Up to approximately 2 years after last dose of QN-023a
Secondary Relapse-free survival (RFS) of participants Up to approximately 2 years after last dose of QN-023a
Secondary Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood 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 Up to approximately 2 years after last dose of QN-023a
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04623944 - NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS Phase 1
Not yet recruiting NCT06313437 - Revumenib in Combination With 7+3 + Midostaurin in AML Phase 1
Terminated NCT04079738 - Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib Phase 1/Phase 2
Recruiting NCT06052813 - A Study of BN104 in the Treatment of Acute Leukemia Phase 1/Phase 2
Recruiting NCT06027853 - Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia Phase 1
Completed NCT02986620 - Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
Recruiting NCT06066905 - A Study of Chidamide With AZA in MRD Positive AML After Transplant N/A
Recruiting NCT05909501 - Assessment of Geriatric Evaluations Impact on New AML Guidance
Terminated NCT04614636 - FT538 in Subjects With Advanced Hematologic Malignancies Phase 1
Not yet recruiting NCT06420063 - Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML Phase 1/Phase 2
Withdrawn NCT04128020 - Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia Phase 1
Active, not recruiting NCT04749355 - Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS Phase 2
Active, not recruiting NCT04755244 - A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05) Phase 1/Phase 2
Completed NCT03194685 - Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Recruiting NCT03884829 - A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS Phase 1
Active, not recruiting NCT05177731 - Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML Phase 3
Not yet recruiting NCT06377579 - OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia
Recruiting NCT05025098 - Precision Therapy Versus Standard Therapy in AML and MDS in Elderly Phase 2
Not yet recruiting NCT06263387 - Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine
Not yet recruiting NCT06188182 - D-index as a Predictor of Complication of Treatment of Patients With Acute Myeloid Leukemia