Natural Killer(NK) Cell Therapy in r/r AML

Sponsor

Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05665114

Collaborator

Hangzhou Qihan Biotech Co.,Ltd. (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML).

This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.

Condition or Disease	Intervention/Treatment	Phase
AML, Adult	Drug: QN-030a Drug: Cyclophosphamid Drug: Fludarabine Drug: Cytarabine Drug: VP-16	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Study on the Safety and Efficacy of QN-030a in Acute Myeloid Leukemia

Anticipated Study Start Date :

Dec 24, 2022

Anticipated Primary Completion Date :

Dec 24, 2023

Anticipated Study Completion Date :

Dec 24, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QN-030a QN-030a in Adult subjects with r/r AML	Drug: QN-030a NK cell therapy Drug: Cyclophosphamid Lympho-conditioning Agent Drug: Fludarabine Lympho-conditioning Agent Drug: Cytarabine Lympho-conditioning Agent Drug: VP-16 Lympho-conditioning Agent

Arm

Intervention/Treatment

Experimental: QN-030a

QN-030a in Adult subjects with r/r AML

Drug: QN-030a

NK cell therapy

Drug: Cyclophosphamid

Lympho-conditioning Agent

Drug: Fludarabine

Lympho-conditioning Agent

Drug: Cytarabine

Lympho-conditioning Agent

Drug: VP-16

Lympho-conditioning Agent

Outcome Measures

Primary Outcome Measures

Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability] [Up to approximately 2 years after last dose of QN-030a]
Incidence of dose adjustment or discontinuation due to NK cell toxicities [Up to approximately 2 years after last dose of QN-030a]
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort [28 Days from first dose of QN-030a]
Determine the Maximum tolerated dose (MTD) and RP2D [28 Days from first dose of QN-030a]

Secondary Outcome Measures

Overall Response Rate(ORR) of QN-030a in r/r AML [Up to approximately 2 years after last dose of QN-030a]
Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator.
Relapse-free survival (RFS) of QN-030a in r/r AML [Up to approximately 2 years after last dose of QN-030a]
Time to Response (TTR) of QN-030a in r/r AML [Up to approximately 2 years after last dose of QN-030a]
Event-free survival (EFS) of QN-030a in r/r AML [Up to approximately 2 years after last dose of QN-030a]
Overall Survival (OS) of QN-030a in r/r AML [Up to approximately 2 years after last dose of QN-030a]
Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood [Up to approximately 2 years after last dose of QN-030a]
The PK of QN-030a in peripheral blood will be reported as the relative percentage of product (QN-030a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points
Evaluate the immunogenicity features of QN-030a [Up to approximately 2 years after last dose of QN-030a]
The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Provision of signed and dated informed consent form (ICF)
≥18 years old
Diagnosis of r/r AML
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 drugs/therapies within certain time of day 0 (first QN-030a 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of medical college of zhejiang university	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Zhejiang University
Hangzhou Qihan Biotech Co.,Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

He Huang, Dr., Zhejiang University

ClinicalTrials.gov Identifier:

NCT05665114

Other Study ID Numbers:

QN030aAL

First Posted:

Dec 27, 2022

Last Update Posted:

Jan 3, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cytarabine

Cyclophosphamide

Fludarabine

Study Results

No Results Posted as of Jan 3, 2023