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IgG4 Related DiseaseEarly Phase 1NCT07298590

An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK in the Treatment of Relapsed and Refractory IgG4-related Disease

A Early Phase 1 study testing CD19/BCMA CAR NK in people with IgG4 Related Disease, run by Changhai Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19/BCMA CAR NK cells (KN5601) in patients with IgG4 related diseases. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
IgG4 Related Disease
What is being tested?
CD19/BCMA CAR NK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
30 Dec 2025to 26 Dec 2028
Phase
Early 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be able to understand and provide informed consent and be willing to comply with study procedures and follow-up.
  • The age at the time of signing the informed consent must be at least 18 years old and no more than 70 years old.
  • Meet the 2020 Japanese criteria or ACR/EULAR IgG4-RD classification criteria.
  • Subjects with relapsed/refractory active IgG4-RD at screening on an IgG4-RD RI ≥4, simultaneously meeting the following definitions of relapse or refractory disease:
  • Definitions of relapse: subjects with IgG4-RD achieved remission after treatment but was active again before screening, and were classified as a high-risk group for recurrence assessed by assessment committee ;
  • Definitions of before screening: subjects had used glucocorticoids or glucocorticoids combined with at least one conventional synthetic disease-modifying antirheumatic drug (csDMARDs) (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, elorimod, thalidomide, etc.), or at least one approved biologic agent (bDMARDs) (including rituximab, abatacept, etanercept, belimumab, etc.), or targeted synthetic (ts) DMARDs (including tofacitinib, upadacitinib, baricitinib, abrocitinib, deucravacitinib, etc.) for treatment, with a total treatment duration of ≥3 months, yet still in an active disease state, ineffective, intolerant, or experiencing relapse during glucocorticoid tapering.
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  • No history of severe allergic reaction.
  • Female participants of childbearing age must have a negative pregnancy test upon enrollment in the study; indeterminate results will not be accepted.
  • Female subjects of childbearing age and male subjects with female partners of childbearing potential must agree to consistently use effective methods of birth control within 6 months after the last KN5601 infusion.
  • Echocardiography show that the heart structure is basically normal and the left ventricular ejection fraction (LVEF) is ≥55%; no obvious abnormalities are found on the electrocardiogram.
  • Pulmonary function: No severe lung disease, SpO2 ≥ 92%.
  • All subjects' eligibility for enrollment must be confirmed by an independent Assessment Committee (AC) (the committee consists of independent data monitors and clinical experts separate from the study). They will review the eligibility of each patient based on the scores entered at screening, as well as brief descriptions provided by the investigators regarding the supporting diagnosis, scores, and the patient's clinical status in relation to enrollment criteria..

Who cannot join

  • Presence of a condition other than IgG4-RD that (e.g., asthma) is likely to require systemic Glucocorticoids (GC) for disease control during the period of the trial.
  • Malignancy within 5 years (except successfully treated in situ cancer, resected squamous cell or basal cell carcinoma of the skin.).
  • During the screening visit, one of the following laboratory test values must be met, except for those caused by IgG4-RD.:
  • Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than three times the upper limit of normal (ULN).
  • Total bilirubin > two times the ULN unless caused by Gilbert's disease. Gilbert's disease with total bilirubin > three times ULN.
  • White blood cell (WBC) count <3.0×10⁹/L;
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  • Absolute neutrophil count (ANC) <1.5×10⁹/L;
  • Hemoglobin <90 g/L;
  • Platelet count <75×10⁹/L;
  • Estimated glomerular filtration rate (eGFR) ≤ 45 ml/(min·1.73m2).
  • Evidence suggests the presence of another uncontrolled disease, which the investigator has determined may affect the subject's participation in the trial.
  • Active infection requiring hospitalization or treatment with systemic antimicrobial agents within the 30 days prior to treatment allocation/randomization.
  • Received rituximab or other B-cell depleting therapies within 6 months prior to the baseline visit, unless B cells have recovered (B-cell recovery is defined as peripheral blood B-cell count ≥ the lower limit of normal reference range or returned to pre-treatment levels)。
  • The use of supplemental oxygen at baseline.
  • During the screening visit or within 90 days prior to the screening visit: T-SPOT positive. If the result is indeterminate, the T-SPOT must be repeated (using the same or a different T-SPOT) and shown as negative.
  • During screening visits, individuals with a history of chronic infection or serological evidence, including:
  • Human immunodeficiency virus infection;
  • Hepatitis B as indicated by surface antigen or hepatitis B core antibody positivity;
  • Hepatitis C as indicated by anti-hepatitis C antibody positivity; if a participant is Hepatitis C antibody positive, they will be eligible to participate in the study if he/she is negative for viral load at screening.
  • Planned vaccination with live vaccines during the trial.
  • Participant is pregnant or breastfeeding, or planning a pregnancy while enrolled in the study.
  • IgG4-RD that is dominated primarily by advanced fibrotic lesions. Specifically, participants whose disease manifestations consist only of
  • retroperitoneal fibrosis,
  • fibrosing mediatinitis,
  • sclerosing mesenteritis, and
  • Riedel's thyroiditis. Subjects were eligible to be included only if they had non-advanced fibrotic disease in at least one organ system and otherwise met the inclusion and exclusion criteria.
  • Evidence a SARS-CoV-2 (COVID-19) infection started within the 30 days prior to treatment allocation/randomization. Participants diagnosed with SARS-CoV-2 (COVID-19) infection more than 30 days prior to treatment .allocation/randomization must have symptoms resolved and be deemed fit to participate in the trial.
  • Researchers consider any situations that may increase the risk to participants or interfere with the trial results (including but not limited to a history of mental illness, alcoholism, drug abuse, poor compliance, etc.).

Trial locations and contacts

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

Lei Xin contact

086-13817318134

aip_xin@163.com

China1 site

  • Changhai Hospital

    Shanghai, 200433

    Zhuan Liao, professor, 86-021-31161004, liaozhuan@smmu.edu.cn

Other trials in China

About this study

Official title: An Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-NK (KN5601) in the Treatment of Relapsed and Refractory IgG4-related Disease (IgG4-RD)

A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19/BCMA CAR NK cells (KN5601) in patients with IgG4 related diseases.

Being tested
CD19/BCMA CAR NK
Medical subject headings
Immunoglobulin G4-Related Disease

What participants receive

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

  • CD19/BCMA CAR NKBiological

    Patients will receive Fludarabine and Cyclophosphamide on day -5, -4, and -3. Multiple doses of CD19/BCMA CAR NK cells will infused using the dose-escalation strategy.

Study groups in NCT07298590
Study groupRoleWhat they receive
This study is a single-arm, open-label and single-center exploratory clinical studyExperimentalNot described
Receives: Biological: CD19/BCMA CAR NK

What is being measured

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

  1. Incidence of Dose-Limiting Toxicity (DLT)

    To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: up to 48 weeks

  2. Incidence of Treatment Emergent Adverse Events (TEAEs)

    To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: up to 48 weeks

  3. The percentage of disease remission (Remission is defined as IgG4-RD RI=0 after treatment and without the use of hormones

    To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: 24 weeks

Secondary outcomes (10)

  1. Percentage of disease remission of IgG4-RD RI score compared with baseline

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: 12, 24, 48 weeks

  2. Percentage of complete response, partial response, and no change (NC)

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: 12, 24, 48 weeks

  3. Disease recurrence rate

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: 24, 48 weeks after infusion

  4. Physician Global Assessment (PhGA) compared with baseline

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related disease

    Measured: up to 48 weeks

  5. Patient Global Assessment (PGA) compared with baseline

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related disease

    Measured: 12, 24, 48 weeks

  6. Disease-related Injury Score

    To characterize the safety of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: 12, 24, 48 weeks

  7. Health Survey by Health Status Questionnaire (SF-36)

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: up to 48 weeks

  8. Assessment of organ function compared with baseline based on MRl imaging

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: up to 48 weeks

  9. Assessment of the affected tissues and organs compared with baseline based on CT imaging examination

    To characterize the efficacy of CD19/BCMA CAR NK Cells (KN5601) for IgG4 related diseases

    Measured: up to 48 weeks

  10. Assessment of persistence of KN5601 after infusion

    To detect CAR copy numbers of KN5601 in peripheral blood

    Measured: up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion26 Jun 2028 (estimated)
  4. Study completion26 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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07298590
Sponsor's protocol ID
CHEC2025-364
Other IDs
CHEC2025-473
Status last verified
Sep 2025
First submitted
17 Nov 2025
Last updated
23 Dec 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 Early Phase 1 study testing CD19/BCMA CAR NK in people with IgG4 Related Disease, run by Changhai Hospital 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 12 inclusion and 28 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: opening soon, as of the sponsor's last update on 23 Dec 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Contact Lei Xin (086-13817318134, aip_xin@163.com), 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 (DLT) (time frame: up to 48 weeks). The study lists 3 primary outcomes in all. 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 NCT07298590.

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 23 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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