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Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05601466
Collaborator
Hangzhou Qihan Biotech Co.,Ltd. (Other)
18
Enrollment
1
Location
1
Arm
35.8
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-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.

Condition or Disease Intervention/Treatment Phase
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 QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia
Anticipated Study Start Date :
Oct 28, 2022
Anticipated Primary Completion Date :
Oct 21, 2025
Anticipated Study Completion Date :
Oct 21, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: QN-023a

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

Drug: QN-023a
NK cell therapy

Drug: Cyclophosphamid
Lympho-conditioning Agent

Drug: Fludarabine
Lympho-conditioning Agent

Drug: Cytarabine
Lympho-conditioning Agent

Outcome Measures

Primary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [28 Days from first dose of QN-023a]

  2. The incidence of subjects with Dose Limiting Toxicities within each dose level cohort [28 Days from first dose of QN-023a]

Secondary Outcome Measures

  1. Overall Response Rate(ORR) [Up to approximately 2 years after last dose of QN-023a]

  2. Relapse-free survival (RFS) of participants [Up to approximately 2 years after last dose of QN-023a]

  3. Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood [Up to approximately 2 years after last dose of QN-023a]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Hematology & Blood Diseases Hospital Tianjin Tianjin China

Sponsors and Collaborators

  • Institute of Hematology & Blood Diseases Hospital
  • Hangzhou Qihan Biotech Co.,Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
wang, jianxiang, Professor, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier:
NCT05601466
Other Study ID Numbers:
  • QN023aTXM1
First Posted:
Nov 1, 2022
Last Update Posted:
Nov 7, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Cytarabine
Cyclophosphamide
Fludarabine

Study Results

No Results Posted as of Nov 7, 2022