Natural Killer (NK) Cell Therapy for B-Cell Malignancies
QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies
1 other identifier
interventional
24
1 country
1
Brief Summary
This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 4, 2021
CompletedFirst Submitted
Initial submission to the registry
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
May 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMay 18, 2022
May 1, 2022
2.6 years
May 13, 2022
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, nature, and severity of treatment related adverse events will be evaluated.
Day 28
Secondary Outcomes (6)
Objective response rate (ORR) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma
From baseline tumor assessment up to approximately 2 years after last dose of QN-019a
Duration of response (DOR) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma
Up to approximately 2 years after last dose of QN-019a
Progression-free survival (PFS) of QN-019a in combination with Rituximab in r/r B-cell Lymphoma
Up to approximately 2 years after last dose of QN-019a
Overall survival (OS) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma
Up to approximately 2 years after last dose of QN-019a
Determination of the pharmacokinetics (PK) of QN-019a cells in peripheral blood
Up to approximately 2 years after last dose of QN-019a
- +1 more secondary outcomes
Study Arms (2)
QN-019a in Combination with Monoclonal Antibodies
EXPERIMENTALQN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.
QN-019a Monotherapy
EXPERIMENTALQN-019a Monotherapy in adult subjects with r/r B-ALL
Interventions
Experimental Interventional Therapy
Lympho-conditioning Agent
Lympho-conditioning Agent
Lympho-conditioning Agent
Eligibility Criteria
You may qualify if:
- Diagnosis of B-cell lymphoma or B-ALL as described below:
- 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
- +1 more criteria
You may not qualify if:
- ALL SUBJECTS:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Universitylead
- Hangzhou Qihan Biotech Co., Ltd.collaborator
Study Sites (1)
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
He Huang, PhD
First Affiliated Hospital of Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 13, 2022
First Posted
May 18, 2022
Study Start
November 4, 2021
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
May 18, 2022
Record last verified: 2022-05