B-cell LymphomaPhase 1NCT05379647
Natural Killer (NK) Cell Therapy for B-Cell Malignancies
A Phase 1 study testing QN-019a, Rituximab and Cyclophosphamid in people with B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphoma, B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- QN-019a, Rituximab and Cyclophosphamid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2021to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
About this study
Official title: QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies
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.
- Being tested
- QN-019a, Rituximab, Cyclophosphamid, Fludarabine, VP-16
- Medical subject headings
- Lymphoma, B-Cell, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QN-019aDrug
Experimental Interventional Therapy
RituximabDrug
Monoclonal Antibody
CyclophosphamidDrug
Lympho-conditioning Agent
FludarabineDrug
Lympho-conditioning Agent
VP-16Drug
Lympho-conditioning Agent
| Study group | Role | What they receive |
|---|---|---|
| QN-019a in Combination with Monoclonal Antibodies | Experimental | QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma. Receives: Drug: QN-019a; Drug: Rituximab; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: VP-16 |
| QN-019a Monotherapy | Experimental | QN-019a Monotherapy in adult subjects with r/r B-ALL Receives: Drug: QN-019a; Drug: Cyclophosphamid; Drug: Fludarabine; Drug: VP-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Measured: Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence, nature, and severity of treatment related adverse events will be evaluated.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to approximately 2 years after last dose of QN-019a
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
Measured: Up to approximately 2 years after last dose of QN-019a
Event-free survival (EFS) of QN-019a as monotherapy in r/r B-ALL
Measured: Up to approximately 2 years after last dose of QN-019a
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start4 Nov 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Qihan Biotech Co., Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379647
- Sponsor's protocol ID
- NK-002 (QN-019a)
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QN-019a as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies in Subjects With B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT05379647
- Acronym / sponsor ID
- NK-002 (QN-019a)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Qihan Biotech Co., Ltd.
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QN-019a in Combination with Monoclonal Antibodies | Experimental | Drug: QN-019a, Drug: Rituximab, Drug: Cyclophosphamid, Drug: Fludarabine, Drug: VP-16QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma. |
| QN-019a Monotherapy | Experimental | Drug: QN-019a, Drug: Cyclophosphamid, Drug: Fludarabine, Drug: VP-16QN-019a Monotherapy in adult subjects with r/r B-ALL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of B-cell lymphoma or B-ALL as described below:
- 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)
- Diagnosis of B-ALL that expected to express CD19
- Relapsed/refractory disease following prior systemic treatment regimens
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QN-019aExperimental Interventional Therapy | Drug | QN-019a Monotherapy, QN-019a in Combination with Monoclonal Antibodies |
| RituximabMonoclonal Antibody | Drug | QN-019a in Combination with Monoclonal Antibodies |
| CyclophosphamidLympho-conditioning Agent | Drug | QN-019a Monotherapy, QN-019a in Combination with Monoclonal Antibodies |
| FludarabineLympho-conditioning Agent | Drug | QN-019a Monotherapy, QN-019a in Combination with Monoclonal Antibodies |
| VP-16Lympho-conditioning Agent | Drug | QN-019a Monotherapy, QN-019a in Combination with Monoclonal Antibodies |
Primary outcome
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
Time frame: Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Day 28
Incidence, nature, and severity of treatment related adverse events will be evaluated.
6 secondary outcomes
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
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
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
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
Determination of the pharmacokinetics (PK) of QN-019a cells in peripheral blood
Time frame: Up to approximately 2 years after last dose of QN-019a
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, PhD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QN-019a, Rituximab and Cyclophosphamid in people with B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of subjects with Dose Limiting Toxicities within each dose level cohort (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.