B-cell Non Hodgkin LymphomaPhase 1NCT04887012
Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL
A Phase 1 study testing anti-CD19 CAR-NK in people with B-cell Non Hodgkin Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma
- What is being tested?
- anti-CD19 CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 May 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in this study and sign an informed consent form;
- Age 18-75 years old, no gender limit;
- Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
- Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ；
- Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;
- Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;
Show all 23Show fewer
- Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;
- At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
- The expected survival period is ≥12 weeks;
- The puncture section of the tumor tissue was positive for CD19 expression;
- ECOG score 0-2 points;
- Sufficient organ function reserve:
- Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
- Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
- Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
- Glomerular filtration rate>50Ml/min
- Cardiac ejection fraction (EF) ≥50%;
- Under natural indoor air environment, basic oxygen saturation>92%
- Allow a previous stem cell transplantation
- The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;
- Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;
- Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial
- Two tests for the new coronavirus were negative.
Who cannot join
- Those who have a history of allergies to any of the ingredients in cell products;
- History of other tumors
- Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
- Have received gene therapy in the past 3 months;
- Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
- Hepatitis B (HBsAg positive, but HBV-DNA <103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis and other subjects with acquired and congenital immunodeficiency diseases, including But not limited to people living with HIV;
Show all 14Show fewer
- According to the New York Heart Association's Heart Function Classification Standard, it is classified as Grade III or Grade IV.
- Impaired subjects;
- Those who have received anti-tumor therapy in the early stage but the toxic reaction has not recovered (the CTCAE 5.0 toxic reaction has not recovered to ≤1, except for fatigue, anorexia, and hair loss);
- Subjects with a history of epilepsy or other central nervous system diseases;
- Enhanced CT or MRI of the head showed evidence of central nervous system lymphoma;
- Have received any other drugs that target CD19;
- Women who are breastfeeding and unwilling to stop breastfeeding;
- Any other situation that the investigator believes may increase the risk of the subject or interfere with the results of the test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Wenbing Qian, +8613605801032, qianwb@zju.edu.cn
About this study
To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma
- Conditions
- B-cell Non Hodgkin Lymphoma
- Being tested
- anti-CD19 CAR-NK
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR-NKBiological
Also called CAR-NK019
lentiviral vector-transducted HLA haploidentical NK cells to express anti-CD19 CAR
| Study group | Role | What they receive |
|---|---|---|
| CAR-NK019 | Experimental | All subjects were intravenously administrated with CAR-NK019 Receives: Biological: anti-CD19 CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
Measured: Up to 28 days
The overall response rate(ORR)
To determine the anti-tumor effectivity of CAR-NK019
Measured: Up to 2 years
Secondary outcomes (4)
Overall survival (OS)
To determine the anti-tumor effectivity of CAR-NK019
Measured: Up to 2 years
progression free survival (PFS)
To determine the anti-tumor effectivity of CAR-NK019
Measured: Up to 2 years
Pharmacokinetics of CAR positive cells
The copy number of CAR DNA was measured at the preset follow-up time point.
Measured: Up to 2 years
Pharmacokinetics of CAR-NK cells
The duration of CAR-positive NK cells in circulation was measured by FACs
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 May 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 May 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 Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenbin Qian, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887012
- Sponsor's protocol ID
- IR2021002168
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of HLA Haploidentical CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed B-cell NHL
- ClinicalTrials.gov ID
- NCT04887012
- Acronym / sponsor ID
- IR2021002168
- Conditions
- B-cell Non Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 14 May 2021 (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.
To study the safety and effectiveness of HLA haploidentical CAR-NK cells targeting CD19 in patients with B-cell non-Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-NK019 | Experimental | Biological: anti-CD19 CAR-NKAll subjects were intravenously administrated with CAR-NK019 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Volunteer to participate in this study and sign an informed consent form;
- Age 18-75 years old, no gender limit;
- Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:
- At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;
- The expected survival period is ≥12 weeks;
Key exclusion criteria (14 listed)
- Those who have a history of allergies to any of the ingredients in cell products;
- History of other tumors
- Previously presented with II-IV degree (Glucksberg criteria) acute GvHD or extensive chronic GvHD; or are receiving anti-GvHD treatment;
- Have received gene therapy in the past 3 months;
- Active infections that require treatment (except for simple urinary tract infections and bacterial pharyngitis), but preventive antibiotics, antiviral and antifungal infection treatments are allowed;
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 |
|---|---|---|
| anti-CD19 CAR-NKAlso: CAR-NK019lentiviral vector-transducted HLA haploidentical NK cells to express anti-CD19 CAR | Biological | CAR-NK019 |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: Up to 28 days
To evaluate the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR-NK Cell Therapy for B-cell Non-Hodgkin Lymphoma
The overall response rate(ORR)
Time frame: Up to 2 years
To determine the anti-tumor effectivity of CAR-NK019
4 secondary outcomes
Overall survival (OS)
Time frame: Up to 2 years
progression free survival (PFS)
Time frame: Up to 2 years
Pharmacokinetics of CAR positive cells
Time frame: Up to 2 years
Pharmacokinetics of CAR-NK cells
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
Related trials for B-cell Non Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
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.
Wenbin Qian principal investigator
2nd Affiliated Hospital, School of Medicine, 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 anti-CD19 CAR-NK in people with B-cell Non Hodgkin Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 23 inclusion and 14 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 14 May 2021. 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 Wenbin Qian (+8613605801032, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) (time frame: Up to 28 days). 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 14 May 2021.