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Autoimmune DiseasesPhase 1NCT07305116

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease

A Phase 1 study testing UCAR T-cell in people with Autoimmune Diseases and Systemic Lupus Erthematosus (SLE), run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease. Read more about this study

Who is it for?
Ages 3 years and older
What is being tested?
UCAR T-cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
1 Dec 2025to Dec 2029
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 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Common Inclusion Criteria:
  • 1. Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):
  • Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; b. Hemoglobin ≥ 60 g/L; c. Platelet count ≥ 30 × 10⁹/L.
  • Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).
  • Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR < 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)
  • Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.
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  • Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%. 2. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.
  • 3. Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.
  • Disease-Specific Inclusion Criteria
  • SLE:
  • Age ≥ 5 years.
  • Meets the 2012 SLICC or 2019 EULAR/ACR classification criteria for SLE.
  • Must meet at least one of the following adequate treatment conditions:
  • Treated with glucocorticoids (≥1 mg/kg/day prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, thalidomide, belimumab, or rituximab) for at least 3 months.
  • Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.
  • Patients who cannot taper glucocorticoids to ≤5 mg/day after 6 months of conventional therapy.
  • SLE disease activity: SLEDAI-2K score ≥ 8; or SLEDAI ≥ 6 plus at least one BILAG-2004 category A or two category B scores, or both.
  • No occurrence of macrophage activation syndrome within 1 month prior to screening.
  • Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.
  • MDR-SRNS
  • Age ≥3 years old, gender unlimited.
  • Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;
  • Must meet at least one of the following adequate treatment conditions:
  • have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).
  • if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.
  • Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.
  • Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.
  • Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);
  • IgA nephropathy
  • Age: ≥ 5 years old, gender unlimited;
  • IgA nephropathy pathologically confirmed by renal biopsy;
  • Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:
  • Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg/mg; b) >50% decline in eGFR within 3 months; c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;
  • Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.
  • Refractory/Relapsed/Progressive Systemic Sclerosis:
  • Age: ≥ 5 years old, gender unlimited;
  • Scleroderma fulfilling the 2013 ACR classification criteria
  • Positive scleroderma-related antibodies.
  • Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).
  • Must meet at least one of the following adequate treatment conditions:
  • Treated with glucocorticoids (≥0.5 mg/kg/day) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.
  • Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.
  • Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.
  • Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure >45 mmHg, or other severe involvement of major organs will be exclude.
  • Refractory/Relapsed ANCA-Associated Vasculitis:
  • Age: ≥ 5 years old, gender unlimited;
  • Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR/EULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).
  • Has received glucocorticoids (≥1 mg/kg/day) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, telitacicept, etc.) for at least 3 months without achieving sustained remission, or has experienced relapse after remission;or meets the criteria for severe vasculitis (Appendix 1), with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.
  • Evidence of active vasculitis meeting the following criteria: For participants <18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.
  • Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.

Who cannot join

  • 1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.
  • 2. Subjects with grade III or IV heart failure (NYHA classification). 3. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.
  • 4. Uncontrollable infection, or active infection that requires systemic treatment at screening.
  • 5. Had active pulmonary tuberculosis at screening. 6. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.
  • 7. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.
  • 8. Patients had active central nervous system disease. 9. Patients with malignant diseases such as tumors before screening. 10. Secondary or congenital immunodeficiency. 11. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.
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  • 12. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.
  • 13. Received live vaccine within 4 weeks before screening. 14. Tested positive in Blood pregnancy test. 15. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.
  • 16. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.
  • 17. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Trial locations and contacts

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

Jianhua Mao, PhD contact

13516819071

maojh88@zju.edu.cn

China1 site, 1 recruiting
  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.

Read the detailed description

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in Patients With B cell mediated autoimmune disease.

Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide. Interim analysis will be performed when participants finish the visit 12 and 24 weeks after CART-cell infusion.

Being tested
UCAR T-cell
Keywords
CAR-T, Multi-Drug Resistant Nephrotic Syndrome, Systemic Lupus Erthematosus, IgAN - IgA Nephropathy, Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV)
Medical subject headings
Autoimmune Diseases, Nephrotic Syndrome, Glomerulonephritis, IGA, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

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

  • UCAR T-cellBiological

    Universal allogeneic anti-CD19/BCMA CAR T-cells.

Study groups in NCT07305116
Study groupRoleWhat they receive
UCAR T-cell groupExperimentalUniversal allogeneic anti-CD19/BCMA CAR T-cells
Receives: Biological: UCAR T-cell

What is being measured

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

  1. The number and severity of dose-limiting toxicity (DLT) events

    The number and severity of dose-limiting toxicity (DLT) events DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

    Measured: Within 28 Days After UCAR T-cell Infusion

Secondary outcomes (6)
  1. Cmax of CAR-T cells [PK parameter]

    The peak plasma concentration (Cmax) of amplified UCAR-T cells in peripheral blood after infusion.

    Measured: Within 28 Days After UCAR T-cell Infusion

  2. Tmax of CAR-T cells [PK parameter]

    The time of amplified UCAR-T cells in peripheral blood to reach the maximum concentration (Tmax).

    Measured: Within 28 Days After UCAR T-cell Infusion

  3. AUC 0-28d of UCAR-T cells [PK parameter]

    The area under the plasma concentration-time curve from 0 to 28 days after infusion (AUC0-28d).

    Measured: Within 28 Days After UCAR T-cell Infusion

  4. The degree of B cell depletion [PD parameter]

    The degree of B cell depletion at various time points.

    Measured: Up to 12 Months After UCAR T-cell Infusion

  5. The concentration levels of IL-6 [PD parameter]

    UCAR-T-related serum cytokines include IL-6.

    Measured: Up to 12 Months After UCAR T-cell Infusion

  6. The changes of anti-ds-DNA antibody after infusion [PD parameter ]

    Measured: Up to 12 Months After UCAR T-cell Infusion

Timeline

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

  1. First posted26 Dec 2025
  2. Study start1 Dec 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2029 (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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07305116
Sponsor's protocol ID
QH-ZE-01
Status last verified
Jan 2026
First submitted
30 Nov 2025
Last updated
3 Feb 2026
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 UCAR T-cell in people with Autoimmune Diseases and Systemic Lupus Erthematosus (SLE), run by The Children's Hospital of 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 50 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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?

Contact Jianhua Mao, PhD (13516819071, maojh88@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and severity of dose-limiting toxicity (DLT) events (time frame: Within 28 Days After UCAR T-cell Infusion). 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 3 Feb 2026.

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