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Refractory/Recurrent Central Nervous System LymphomaPhase 1NCT06827782

Cord Blood-derived CAR-NK Cells Targeting CD19 for Refractory/Relapsed Central Nervous System Lymphoma

A Phase 1 study testing anti-CD19 CAR-NK cells in people with Refractory/Recurrent Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study is designed to evaluate the safety and efficacy of cord blood-derived CAR-NK019 in the treatment of refractory/relapsed central nervous system lymphoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
anti-CD19 CAR-NK cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
1 Mar 2025to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Patients with refractory/recurrent CNS lymphoma must meet all of the following criteria to be eligible:
  • Voluntarily participate in the study and sign the informed consent;
  • Age 18-75 years old, male or female;
  • Diffuse large B-cell lymphoma (DLBCL) was confirmed by histology. CD19 expression was positive by lymphoma pathology or flow cytometry, and CD19 expression was ≥20% by IHC.
  • Imaging showed no evidence of systemic lymphoma;
  • Meets any of the following definitions for refractory/relapsed CNS lymphoma: no complete response has been achieved with prior 2-line regimen including methotrexate or cytarabine-based regimen; Disease progression during any treatment; The stable time of disease after effective treatment is less than 6 months; Disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation.
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  • Imaging showed the presence of at least one measurable lesion, with a minimum diameter of ≥10mm;
  • Expected survival ≥3 months;
  • ECOG score 0-3 points;
  • Adequate organ function reserve:
  • alanine aminotransferase, ASpartate aminotransferase ≤ 2.5× UNL (upper limit of normal);
  • Creatinine clearance (Cockcroft-Gault method) ≥60 mL/min;
  • Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;
  • Glomerular filtration rate >50ml/min
  • cardiac ejection fraction (EF) ≥45%;
  • Basic oxygen saturation >92% in indoor natural air environment;
  • Blood routine: absolute number of neutrophils >×109/L, platelet count 45×109/L, hemoglobin 80g/L;
  • Previous autologous hematopoietic stem cell transplantation is allowed, and the interval between stem cell transfusion and CAR-NK transfusion is ≥3 months;
  • Previous CAR-T cell therapy is allowed, and the time interval between CAR-T transfusion and CAR-NK transfusion is ≥3 months;
  • Female subjects of childbearing age must test negative for pregnancy and agree to use effective contraception during the test;
  • Approved anti-tumor therapies, such as systemic chemotherapy, whole body radiotherapy and immunotherapy, have been discontinued for at least 3 weeks before the study; Discontinuation of targeted drug regiments without chemotherapy for at least 2 weeks;

Who cannot join

  • Subjects who meet any of the following criteria will not be admitted to the study:
  • Allergic to any of the components of cell products;
  • History of other tumors;
  • Acute grade II-IV (Glucksberg standard) GvHD or generalized chronic GvHD occurred after previous allogeneic hematopoietic stem cell transplantation; Or are receiving anti-GVHD treatment;
  • Have received gene therapy within the past 3 months;
  • Active infections requiring treatment (except simple urinary tract infections, bacterial pharyngitis), but prophylactic antibiotic, antiviral and antifungal infection treatment is permitted;
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  • Persons infected with hepatitis B (HBsAg positive, but HBV-DNA<103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;
  • Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association's cardiac function grading criteria;
  • Patients who received antitumor therapy in the early stage but did not recover toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);
  • Previous history of epilepsy, autoimmune encephalitis, cerebral infarction or cerebral hemorrhage within 6 months;
  • Whole-body enhanced CT or PET/CT suggests evidence of systemic lymphoma;
  • Lactating women who are unwilling to stop breastfeeding;
  • Any other circumstances that the investigator believes may increase the risk to the subject or interfere with the test results;
  • Patients requiring more than 10mg of dexamethasone per day for 3 days prior to enrollment;
  • Patients who cannot tolerate ommaya capsule implantation;
  • Those who cannot tolerate enhanced magnetic resonance imaging.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Clinical Study of Cord Blood-derived CAR-NK Cells Targeting CD19 in the Treatment of Refractory/Relapsed Central Nervous System Lymphoma

This study is designed to evaluate the safety and efficacy of cord blood-derived CAR-NK019 in the treatment of refractory/relapsed central nervous system lymphoma.

Read the detailed description

This study is a single-center, open, single-arm incremental, exploratory study designed to evaluate the safety and efficacy of cord blood-derived CAR-NK019 in the treatment of refractory/relapsed central nervous system lymphoma.

The study will be divided into two stages: Phase I is the dose escalation study, which is strictly based on the "3+3" dose escalation principle, and three dose groups are set up, which are administered through the ommaya capsule ventricle, and each dose is infused once a week for 3 weeks. Three to six subjects are intended to be enrolled in each dose group, with each subject observed for at least 28 days after receiving the initial infusion and a long-term follow-up period of two years after each infusion. Phase II is the dose expansion phase: The recommended dose and administration mode for this phase will be determined after comprehensive consideration based on safety data obtained in phase I, the proliferation and survival of CAR-NK cells in vivo, and clinical efficacy data, and 24 effective subjects will be recruited for further evaluation of efficacy and safety. Long-term follow-up lasted up to 2 years after the first CAR-NK transfusion in each patient.

Being tested
anti-CD19 CAR-NK cells
Keywords
Refractory or recurrent, central nervous system lymphoma, Diffuse large B cell lymphoma, CAR-NK
Medical subject headings
Recurrence, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD19 CAR-NK cellsBiological

    lentiviral vector-transducted cord blood-derived NK cells to express anti-CD19 CAR

Study groups in NCT06827782
Study groupRoleWhat they receive
CB CAR-NK019ExperimentalNot described
Receives: Biological: anti-CD19 CAR-NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicity (DLTs)

    To evaluate the safety, tolerability, and determine the recommended dosage of cord blood-derived Anti-CD19 CAR-NK Cell Therapy for refractory/relapsed central nervous system lymphoma

    Measured: Up to 28 days

Secondary outcomes (5)

  1. Complete response rate (CR)

    To determine the anti-tumor effectivity of CB CAR-NK019

    Measured: 3 months

  2. Overall response rate (ORR)

    To determine the anti-tumor effectivity of CB CAR-NK019

    Measured: 3 months

  3. Progression free survival (PFS)

    To determine the anti-tumor effectivity of CB CAR-NK019

    Measured: Up to 2 years

  4. Overall survival (OS)

    To determine the anti-tumor effectivity of CB CAR-NK019

    Measured: Up to 2 years

  5. Duration of response (DOR)

    To determine the anti-tumor effectivity of CB CAR-NK019

    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.

  1. First posted14 Feb 2025
  2. Study start1 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827782
Sponsor's protocol ID
ID2024482
Status last verified
Dec 2024
First submitted
29 Dec 2024
Last updated
15 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CD19 CAR-NK cells in people with Refractory/Recurrent Central Nervous System 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 21 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827782.

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 15 Aug 2025.

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