Natural Killer (NK) Cell Therapy for B-Cell Malignancies
NCT ID: NCT05379647
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2021-11-04
2024-12-31
Brief Summary
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This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.
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Detailed Description
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This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 24-36 patients will be enrolled.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QN-019a in Combination with Monoclonal Antibodies
QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.
QN-019a
Experimental Interventional Therapy
Rituximab
Monoclonal Antibody
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
VP-16
Lympho-conditioning Agent
QN-019a Monotherapy
QN-019a Monotherapy in adult subjects with r/r B-ALL
QN-019a
Experimental Interventional Therapy
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
VP-16
Lympho-conditioning Agent
Interventions
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QN-019a
Experimental Interventional Therapy
Rituximab
Monoclonal Antibody
Cyclophosphamid
Lympho-conditioning Agent
Fludarabine
Lympho-conditioning Agent
VP-16
Lympho-conditioning Agent
Eligibility Criteria
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Inclusion Criteria
B-cell Lymphoma:
* Histologically documented lymphomas expected to express CD19 and CD20
* Relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (HSCT)
B-ALL:
* Diagnosis of B-ALL that expected to express CD19
* Relapsed/refractory disease following prior systemic treatment regimens
ALL SUBJECTS:
* Provision of signed and dated informed consent form (ICF)
* Age ≥ 18 years old
* Stated willingness to comply with study procedures and duration
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-019a: MFI \<= 2000
* At least 3 weeks after the last systemic immunochemotherapy treatment
* The estimated survival days are expected to be over 3 months
Exclusion Criteria
* Females who are pregnant or lactating
* Evidence of insufficient organ function as defined in the protocol
* ECOG Performance Status ≥2
* Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T/CAR-NK within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
* Currently receiving or likely to require systemic immunosuppressive therapy
* Known active central nervous system (CNS) involvement by malignancy. Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease
* Clinically significant cardiovascular disease as defined in the protocol
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* Donor specific antibody (DSA) to QN-019a: MFI \> 2000
* Other comorbid conditions and concomitant medications prohibited as per study protocol
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
18 Years
ALL
No
Sponsors
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Hangzhou Qihan Biotech Co.,Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Clinical Professor
Principal Investigators
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He Huang, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
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The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NK-002 (QN-019a)
Identifier Type: -
Identifier Source: org_study_id
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