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Systemic Lupus Erythematosus (SLE)Phase 1/2NCT06585514

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus

A Phase 1/2 study testing CD19 CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by Beijing GoBroad Hospital 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
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Trial summary

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 3 to 65 years
What is being tested?
CD19 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
17 Oct 2024to 31 Dec 2026
Phase
Phase 1/2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male or female, aged 3-65 years.
  • Have a diagnosis of SLE and meet the classification criteria of 2019 European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).
  • Positive antinuclear antibody (ANA): ANA at a titer of ≥ 1:80 on Hep-2 cells or equivalent positive test (ever) and/or a positive anti-dsDNA serum antibody test (based on ELISA assay, ≥ 30 IU/mL).
  • Refractory SLE and/or refractory lupus nephritis (LN):
  • 4.1 Refractory SLE 4.1.1 Patients received at least 7.5 mg/kg/day of prednisolone to maintain low disease activity or the SLEDAI 2K score ≥8.
  • 4.1.2 Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use glucocorticoid (more than 1mg/kg/d) and cyclophosphamide for 6 months; and any of the following immunomodulatory drugs for more than 3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents such as rituximab, belizumab, or telitacicept;
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  • 4.2 Refractory LN 4.2.1 Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR), Biopsy-proven LN class III, IVa [excluding III (C), IV-S (C) and IV-G (C)] or, class V lupus nephritis combined with class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria, see Appendix 3. Biopsy must be performed within 6 months before or during screening.
  • 4.2.2 Refractory lupus nephritis is defined as no induced remission to treatment regimens containing at least one immunosuppressant (including glucocorticoids, CTX, tacrolimus, MME, and cyclosporine) after 3 to 6 months, accompanied by no reduction (or worsening) of proteinuria or persistent antibody positives.
  • CD19+ on B cells and continuous withdrawal of the immunosuppressive drugs for more than 1 week.
  • The blood routine lymphocyte count of the subjects is \> 1 × 109/L, and there is no cell collection contraindication.
  • No severe allergy.
  • Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
  • Patients are expected to live for at least 90 days.
  • Subjects and/or their guardian must understand and sign the informed consent.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Impaired consciousness or intracranial hypertension:
  • Intracranial pressure elevation was above 15 mmHg;
  • Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, and other brain lesions requiring intervention.
  • Symptomatic congestive heart failure or severe cardiac arrhythmia:
  • Previously documented left ventricular ejection fraction (LVEF) by echocardiography of \<45% in the 12 months;
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  • Abnormal electrocardiogram (ECG): left bundle branch block, bifascicular block or any clinically meaningful ECG abnormality;
  • Congenital long QT syndrome or prolongation of the QT interval corrected for heart rate (QTcF) ≥ 470 ms. QTcF is calculated using Fridericia's Formula;
  • Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification;
  • Unstable or poorly controlled angina pectoris, including the prinzmetal variant of angina pectoris;
  • Myocardial infarction within 6 months.
  • Manifestations of severe respiratory system failure:
  • Hypoxemic respiratory failure: PaO2 \< 60 mmHg, PaCO2 \< 50 mmHg at sea level, resting and breathing air conditions;
  • Subjects with pulmonary hypertension (PH): mean pulmonary artery pressure (mPAP) ≥25 mmHg measured by right heart catheterization (RHC);
  • Subjects with hypercapnia (PaCO2 ≥ 50mmHg ) and/or ventilatory dysfunction (PH \<7.25 );
  • Oxygen inhalation was required to maintain oxygen saturation;
  • Acute or chronic respiratory diseases unrelated to SLE, such as acute pneumonia and interstitial lung disease.
  • Co-existence with other malignancies.
  • Disseminated intravascular coagulation (DIC).
  • Sepsis or other uncontrollable infections: active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection) or other clinically significant active disease process.
  • Uncontrollable diabetes: after at least 3 months of diet and exercise or similar treatment, fasting blood glucose (FBG) ≥ 8.0 mmol/L, postprandial blood glucose (PBG) ≥ 15 mmol/L, and glycosylated hemoglobin (HbA1c)≥8.0%; diabetic ketoacidosis or other uncontrollable complications of diabetes.
  • Serious mental illness: alcohol or drug abuse, dementia, or any other condition that would impair the subject's ability to receive the planned treatment or to understand informed consent at the study site.
  • Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI).
  • Underwent organ transplantation, excepting SCT.
  • Pregnant females or lactation.
  • Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis.
  • No peripheral blood mononuclear cells (PBMC) collection or frozen PBMC for CAR T cell manufacturing.
  • eGFR CKD-EPI \< 30 ml/min/1.73m2.
  • Patients who are unable to discontinue immunosuppression agents for ≥7 days or whose condition recurs during discontinuation while the risk of serious adverse reactions is assessed by the investigator.
  • Any active skin disease that may interfere with the evaluation of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-SLE skin manifestations (e.g., cutaneous vasculopathies, peripapillary dilatation, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers), or drug-induced lupus.

Trial locations and contacts

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

Tengyu Wang contact

18333186020

tengyu.wang@gohealtharo.com

China1 site, 1 recruiting

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 102206

    Recruiting

Other trials in China

About this study

Official title: Open-Label, Non-Randomized, Single-Arm, Phase 1/2 Study of Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus

The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).

Read the detailed description

This is a single-center, open-label, non-randomized, Phase I/II trial. Patients with refractory systemic lupus erythematosus (SLE) will receive CD19 CAR T cells. The primary objective is to learn about the safety and tolerability of CD19 CAR T cell therapy in subjects with refractory SLE and to determine the optimal biological dose (OBD) and recommend phase 2 dose (RP2D) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with refractory SLE in phase II. The primary endpoint is type and incidence of dose limiting toxicity (DLT) within 28 days after CD19 CAR T-cell infusion in phase I and overall response rate (ORR) in phase II. A total number of 18 subjects will be enrolled.

Being tested
CD19 CAR-T cells
Keywords
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), CD19 CAR-T
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis

What participants receive

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

  • CD19 CAR-T cellsDrug

    Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.

Study groups in NCT06585514
Study groupRoleWhat they receive
CD19 CARExperimentalFollowing the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Receives: Drug: CD19 CAR-T cells

What is being measured

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

  1. Phase I: Dose-limiting toxicity (DLT)

    The incidence and type of dose-limiting toxicity (DLT).

    Measured: 28 days post infusion

  2. Phase I: Adverse events (AEs)

    The incidence and severity of adverse events (AE).

    Measured: 30 days post infusion

  3. Phase II: Objective response rate (ORR)

    Proportions of subjects achieving SLE Responder Index (SRI)-4 response

    Measured: 3 months and 6 months post infusion

Secondary outcomes (6)

  1. Phase I: Objective response rate (ORR)

    Proportions of subjects achieving SLE Responder Index (SRI)-4 response.

    Measured: 3 months and 6 months

  2. Phase I: Long-term Adverse events (AEs)

    Total number, incidence and severity of AEs from 30 days to 2 years after CD19 CAR T infusion will be recorded.

    Measured: From 30 days after CD19 CAR T infusion to 2 years

  3. Phase I: Pharmacokinetics

    The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR).

    Measured: Up to 2 years post infusion

  4. Phase II: Adverse events (AEs)

    The incidence and severity of adverse events.

    Measured: 2 years post infusion

  5. Phase II: Pharmacokinetics

    The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR).

    Measured: Up to 2 years post infusion

  6. Phase II: Overall survival (OS) and during of response (DOR)

    Overall survival (OS) is defined the time from the initial CD19 CAR T cell infusion to death for any cause. During of response (DOR) is defined as the date when response criteria are first met to the date of relapse or death caused by SLE in the absence of documented relapse.

    Measured: Up to 2 years post infusion

Timeline

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

  1. First posted5 Sep 2024
  2. Study start17 Oct 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (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 1/2
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
NCT06585514
Sponsor's protocol ID
BJGBYY-IIT-LCYJ-2024-040
Status last verified
Mar 2026
First submitted
3 Sep 2024
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Results will be published anonymized and summarized.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD19 CAR-T cells in people with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by Beijing GoBroad 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 14 inclusion and 30 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 10 Mar 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Tengyu Wang (18333186020, tengyu.wang@gohealtharo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Dose-limiting toxicity (DLT) (time frame: 28 days post infusion). 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 NCT06585514.

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 10 Mar 2026.

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