Natural Killer (NK) Cell Therapy Targeting CD33 in Acute Myeloid Leukemia

NCT05665075 | Unknown Phase 1

• 1 other identifier: QN023aM
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML, Adult

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of Treatment-Emergent Adverse Events[Safety and Tolerability]

  Up to approximately 2 years after last dose of QN-023a

• Incidence of dose adjustment or discontinuation due to NK cell toxicities

  Up to approximately 2 years after last dose of QN-023a

• Incidence of subjects with Dose Limiting Toxicities within each dose level cohort

  28 Days from first dose of QN-023a

• Determine the maximum tolerated dose (MTD) and RP2D

  28 Days from first dose of QN-023a

Secondary Outcomes (7)

• Overall Response Rate(ORR) of QN-023a in r/r AML

  Up to approximately 2 years after last dose of QN-023a

• Relapse-free survival (RFS) of QN-023a in r/r AML

  Up to approximately 2 years after last dose of QN-023a

• Time to Response (TTR) of QN-023a in r/r AML

  Up to approximately 2 years after last dose of QN-023a

• Event-free survival (EFS) of QN-023a in r/r AML

  Up to approximately 2 years after last dose of QN-023a

• Overall Survival (OS) of QN-023a in r/r AML

  Up to approximately 2 years after last dose of QN-023a

Study Arms (1)

QN-023a

EXPERIMENTAL

QN-023a in adult subjects with r/r AML

Drug: QN-023a; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Cytarabine; Drug: VP-16

Interventions

QN-023a DRUG

NK cell therapy

QN-023a

Cyclophosphamid DRUG

Lympho-conditioning Agent

QN-023a

Fludarabine DRUG

Lympho-conditioning Agent

QN-023a

Cytarabine DRUG

Lympho-conditioning Agent

QN-023a

VP-16 DRUG

Lympho-conditioning Agent

QN-023a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead
• Hangzhou Qihan Biotech Co., Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cyclophosphamide; fludarabine; Cytarabine; Etoposide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

He Huang, PhD

CONTACT

86-13605714822; hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

86-15957162012; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 27, 2022
• Study Start: December 24, 2022
• Primary Completion: December 24, 2023
• Study Completion: December 24, 2025
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)