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Systemic Lupus ErythematosusPhase 1/2NCT06106906

A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus

A Phase 1/2 study testing CD19 CAR-T cell infusion in people with Systemic Lupus Erythematosus, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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

The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in active systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
CD19 CAR-T cell infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
19 Jun 2024to Dec 2027
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants or their guardians understand and voluntarily sign the informed consent form, and be able to complete all the documents, procedures, follow-up examinations and treatments specified in the study protocol, with good compliance;
  • Age range from 18 to 70 years old, regardless of gender;
  • Body weight ≥ 40kg;
  • Participants diagnosed with SLE according to the American College of Rheumatology (ACR) 1997 revised criteria for SLE at least 24 weeks prior to signing the informed consent form;
  • Active SLE needs to meet the following criteria at screening:
  • SELENA-SLEDAI score ≥ 6 points; PGA ≥ 1 points;
  • Have received at least 8 weeks of standardized treatment for SLE prior to screening;
  • Female participants need to have a negative pregnancy test, and participants agree to take effective contraceptive measures throughout the study.

Who cannot join

  • Known hypersensitivity to prednisone, immunosuppressive agents;
  • Diagnosis of active severe lupus nephritis within 8 weeks prior to screening, requiring medications prohibited by the research protocol for active nephritis, hemodialysis or prednisone ≥ 100 mg/d, or equivalent glucocorticoid therapy for ≥14 days;
  • Suicidal ideation within the past 6 months based on assessment by Columbia-Suicide Severity Rating Scale (C-SSRS) at screening; or any suicidal behaviors within the past 12 months or recurrent suicidal behaviors during the subject's lifetime;
  • Presence of SLE or non-SLE related central nervous system diseases or pathological changes within 8 weeks prior to screening;
  • Existence of other lupus crisis within 8 weeks prior to screening;
  • Previous or current diagnosis of non-SLE-related inflammatory arthropathy or skin diseases;
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  • Previous or current diagnosis of severe vasculitis due to other diseases excluding SLE;
  • History of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation;
  • Have received plasmapheresis, hemodialysis, intravenous immunoglobulin within 14 days prior to screening;
  • Other autoimmune diseases requiring systemic therapy;
  • Subjects with active viral hepatitis B; Subjects with positive hepatitis C virus (HCV) antibodies; Subjects with positive human immunodeficiency virus (HIV) antibodies; Sujects with positive extracellular DNA quantification of cytomegalovirus (CMV); Sujects with positive extracellular DNA quantification of EB virus (EBV);Subjects tested positive for syphilis;
  • Active or latent tuberculosis at screening (can be enrolled if appropriately treated);
  • Any of severe laboratory abnormalities in liver function, renal function, bone marrow function, coagulation function, pulmonary function, cardiac function at screening;
  • History of severe allergy or known hypersensitivity to any of the active ingredients of the drugs, excipients, or rodent-derived products, xenoproteins included in this trial, or subjects with allergic constitution;
  • Severe heart diseases;
  • Severe hepatobiliary disease;
  • Presence of medical conditions that are obviously unstable or not effectively treated;
  • Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy;
  • Have received live/attenuated vaccination within 4 weeks prior to screening or plan to receive live/attenuated vaccination throughout the study;
  • Have received any commercially available Janus kinase inhibitor or Bruton tyrosine kinase inhibitor within 3 half-lives prior to screening;
  • Have received B-cell targeted therapy prior to screening;
  • Have received a biologic agent other than B-cell targeted therapy within 5 half-lives prior to screening;
  • Previous received therapies with CAR-T cells or other genetically modified T cells;
  • Have received therapeutic dose of corticosteroids within 7 days prior to leukapheresis or within 72 hours prior to infusion;
  • Have received any other study drugs for SLE within 4 weeks prior to leukapheresis;
  • Subjects that have undergone major surgery within 4 weeks prior to lymph depletion or those who are scheduled to undergo major surgery during the study period, or whose surgical wounds have not fully healed prior to enrollment;
  • Subjects that have donated blood for ≥ 400mL or had significant blood loss equivalent to at least 400mL within 4 weeks prior to screening, or have received a blood transfusion within 8 weeks, or plan to donate blood during the study period;
  • History of ≥ grade 2 bleeding within 4 weeks prior to screening or need for long-term continuous anticoagulant therapy;
  • Subjects with severe mental illness;
  • Alcoholics or subjects with a history of drug abuse;
  • Female subjects who are pregnant or lactating, or intend to pursue pregnancy within 2 years after the cell infusion; male patients whose female sexual partners intend to conceive within 2 years after the cell infusion;
  • History of malignancy；
  • Patients that have contraindications to any of the study procedures or have other medical conditions that may expose them to unacceptable risk, in the judgment of the investigators and/or clinical criteria.

Trial locations and contacts

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

Qiubai Li, Professor contact

85726808 ext. 027

qiubaili@hust.edu.cn

China1 site, 1 recruiting

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

    Qiubai Li, Professor, (027) 85726808, qiubaili@hust.edu.cn

    Qiubai Li, Professor

    Recruiting

Other trials in China

About this study

Official title: A Single-center Clinical Study Evaluating the Safety and Efficacy of CD19 CAR-T in Active Systemic Lupus Erythematosus

The purpose of the study is to explore the safety and efficacy of CD19 CAR-T in active systemic lupus erythematosus.

Read the detailed description

The prognosis of patients with active systemic lupus erythematosus (SLE) remains poor, due to two major therapeutic obstacles: (1) current treatment strategies including glucocorticoids, immunosuppressive agents, biological agents, are still difficult to achieve disease control, making the disease condition of some patients continue to be active or even worse; (2) some patients are unable to wean themselves off glucocorticoid and face the risk of numerous adverse effects caused by long-term glucocorticoid dependence, such as glucocorticoid-related diabetes, femoral head necrosis, hypertension, stress ulcers, and infection, etc. Therefore, there is a strong unmet clinical need for more effective treatment for patients suffering from active SLE. Several preclinical studies have shown the efficacy of CAR-T cell treatment in SLE. The aim of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of CD19 CAR-T cell therapy in active SLE. Patients with active SLE will be invited to participate in the study, to receive CD19 CAR-T intravenous infusion and follow-up visits of up to 2 years after enrollment.

Being tested
CD19 CAR-T cell infusion
Keywords
systemic lupus erythematosus, CAR-T, CD19
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

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

  • CD19 CAR-T cell infusionBiological

    CD19 CAR-T cell intravenous infusion

Study groups in NCT06106906
Study groupRoleWhat they receive
Experimental ArmExperimentalParticipants will receive CD19 CAR-T cell intravenous infusion
Receives: Biological: CD19 CAR-T cell infusion

What is being measured

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

  1. Safety and tolerability

    Safety and tolerability will be assessed by incidence and severity of adverse events (AEs) and serious AEs (SAEs). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded by ASTCT criteria, other AEs are assessed by CTCAE V5.0 criteria

    Measured: Within 2 years after CD19 CAR-T cell infusion

Secondary outcomes (11)

  1. Pharmacokinetics (PK)

    Concentration of CD19 CAR-T cells in peripheral blood will be evaluated

    Measured: Within 2 years after CD19 CAR-T cell infusion

  2. Pharmacodynamics (PD)

    Pharmacodynamics (PD) will be assessed by levels of cytokines (IL-2、IL-6、IL-10、IFN-γ) in peripheral blood

    Measured: Within 28 days after CD19 CAR-T cell infusion

  3. Proportion of subjects with SRI-4 response

    SRI-4 response is defined as: 1) the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score decrease by no less than 4 points from baseline; 2) the British Isles Lupus Assessment Group (BILAG) score with no new A domain score and no more than 1 new B domain score compared to baseline; 3) the Physician Global Assessment (PGA) score increase less than 0.3 point from baseline

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  4. Changes in the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score from baseline

    Range [0, 105]，higher score represents worse disease activity

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  5. Changes in the Physician Global Assessment (PGA) score from baseline

    Range [0, 3]，higher score represents worse disease activity

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  6. Changes in immunological indexes from baseline

    Serum IgA, IgG, IgE and IgM will be evaluated

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  7. Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline

    To evaluate SLE disease activity

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  8. Changes in level of anti-double stranded DNA (dsDNA) antibody in peripheral blood from baseline

    To evaluate SLE disease activity

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  9. Changes in levels of complement C3 in peripheral blood from baseline

    To evaluate SLE disease activity

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  10. Changes in levels of complement C4 in peripheral blood from baseline

    To evaluate SLE disease activity

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

  11. Changes in levels of Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) from baseline in patients with cutaneous lupus erythematosus

    Range [0, 70]，higher score represents larger or more severe skin involvement

    Measured: Within 2 years after CD19 CAR-T cell infusion (day 14, day 28, month 3, month 6, month 9, month 12, month 18, month 24)

Timeline

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

  1. First posted30 Oct 2023
  2. Study start19 Jun 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2027 (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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106906
Sponsor's protocol ID
UHCT230444
Status last verified
Jan 2025
First submitted
19 Oct 2023
Last updated
8 Jan 2025
Results posted
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 1/2 study testing CD19 CAR-T cell infusion in people with Systemic Lupus Erythematosus, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 33 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 8 Jan 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 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 Qiubai Li, Professor (85726808 ext. 027, qiubaili@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: Within 2 years after CD19 CAR-T cell infusion). 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 NCT06106906.

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 8 Jan 2025.

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