ClinicalTrials.gg
Sign In
Status unknownNCT05379647Updated May 18, 2022

Natural Killer (NK) Cell Therapy for B-Cell Malignancies

A Phase 1 interventional study of QN-019a and Rituximab in B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia, sponsored by Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by Zhejiang University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2021, registered May 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 24-36 patients will be enrolled.

02

Conditions studied

  • B-cell Lymphoma
  • B-cell Acute Lymphoblastic Leukemia
03

In context

Lymphoma, B-Cell

1,415 studies on the registry are indexed under Lymphoma, B-Cell; 328 are open to participants now.

This study's planned enrollment of 24 is below the median of 36 across 1,221 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

Zhejiang University is the lead sponsor of 355 studies on the registry; 166 are open to participants now.

Browse Zhejiang University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • 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
  • The estimated survival days are expected to be over 3 months

Key Exclusion Criteria:

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    QN-019a in Combination with Monoclonal Antibodies

    QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.

    Drug: QN-019a · Drug: Rituximab · Drug: Cyclophosphamid · Drug: Fludarabine · Drug: VP-16

  • Experimental
    QN-019a Monotherapy

    QN-019a Monotherapy in adult subjects with r/r B-ALL

    Drug: QN-019a · Drug: Cyclophosphamid · Drug: Fludarabine · Drug: VP-16

Interventions

06

What researchers measure

Primary outcomes

  1. The incidence of subjects with Dose Limiting Toxicities within each dose level cohort

    Time frame: Day 28

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence, nature, and severity of treatment related adverse events will be evaluated.

    Time frame: Day 28

Secondary outcomes

  1. 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

    Time frame: From baseline tumor assessment up to approximately 2 years after last dose of QN-019a

  2. 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

    Time frame: Up to approximately 2 years after last dose of QN-019a

  3. Progression-free survival (PFS) of QN-019a in combination with Rituximab in r/r B-cell Lymphoma

    Time frame: Up to approximately 2 years after last dose of QN-019a

  4. Overall survival (OS) of QN-019a as monotherapy in r/r B-ALL and in combination with Rituximab in r/r B-cell Lymphoma

    Time frame: Up to approximately 2 years after last dose of QN-019a

  5. Determination of the pharmacokinetics (PK) of QN-019a cells in peripheral blood

    The PK of QN-019a in peripheral blood will be reported as the relative percentage of product (QN-019a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points

    Time frame: Up to approximately 2 years after last dose of QN-019a

  6. Event-free survival (EFS) of QN-019a as monotherapy in r/r B-ALL

    Time frame: Up to approximately 2 years after last dose of QN-019a

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Medical College of Zhejiang University
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05379647
Lead sponsor
Zhejiang University
Collaborators
Hangzhou Qihan Biotech Co., Ltd.
Responsible party
He Huang (Clinical Professor, Zhejiang University) — Principal investigator
First posted
May 18, 2022
Start date
Nov 4, 2021
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
May 18, 2022

Study contacts

He Huang, PhD
Contact
hehuangyu@126.com
86-13605714822
Yongxian Hu, PhD
Contact
huyongxian2000@aliyun.com
86-15957162012
He Huang, PhD
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma, B-Cell →

Other studies from this sponsor

Zhejiang University →

Start the discussion