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SLEPhase 1/2NCT06839976

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

A Phase 1/2 study testing CART19 in people with SLE and Systemic Lupus Erythematosus (SLE), run by Children's Hospital of Philadelphia at 1 site in United States.

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

This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 10 to 29 years
What is being tested?
CART19
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
6 May 2025to 28 Feb 2030
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 10 to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required window.
  • Patient age must be 10-29 years, inclusive, at time of enrollment.
  • Meeting ACR/EULAR Classification Criteria for SLE
  • ANA positive > 1:80 and/or double-stranded DNA (dsDNA) positive
  • Active (refractory) disease, defined as follows:
  • Lupus nephritis subjects must meet both the following criteria: i. ISN/RPS active nephritis Class III/IV +/- V lupus nephritis diagnosed by biopsy within past 12 months.
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  • Persistent and clinically significant: ≥2 measurements with urine protein with either of the following:
  • > 1mg/mg creatinine
  • > 0.5 mg/mg creatinine associated with renal dysfunction or low albumin.
  • > 0.5 mg/mg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE subjects must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii. Inability to decrease prednisone ≤7.5mg/day or 0.15mg/kg/day, whichever is lower, due to active disease.
  • 6. Patients must have had at least 3 months of cumulative conventional therapy defined as:
  • Conventional induction immunosuppressive agent(s) (e.g., mycophenolate mofetil, cyclophosphamide), and
  • At least one additional therapy:
  • B-cell directed biologic therapy (e.g., rituximab, belimumab, ofatumumab, obinutuzumab) ii. Calcineurin inhibitor (e.g., tacrolimus, cyclosporine, voclosporin) iii. Other immunosuppressive medication for SLE (e.g., anifrolumab, abatacept, JAK inhibitor) 7. Adequate organ function status
  • Renal: eGFR must be ≥30 and subject cannot be receiving dialysis.
  • Hepatic: Transaminases < 5x upper limit of normal and serum conjugated (Direct) bilirubin <1.5x upper limit of normal unless attributable to SLE. If attributable to autoimmune disease, Child-Pugh score must be class A or class B. Child-Pugh score cannot be class C.
  • Cardiac: Shortening fraction > 28%, left ventricular ejection fraction >45%, and no evidence of severe pulmonary hypertension
  • Pulmonary: Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and <Grade 3 hypoxia; DLCO ≥40% (corrected for anemia and/or VA volume if necessary) if PFTs are clinically appropriate as determined by the treating investigator.
  • 8. Subjects of reproductive potential must agree to use acceptable birth control methods.

Who cannot join

  • Active, untreated infections
  • HIV infection
  • Active Hepatitis B
  • Patients must have a negative hepatitis B surface antigen to be enrolled on this study.
  • Active Hepatitis C
  • Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic brain syndrome, or lupus related headaches)
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  • Monogenic lupus (known)
  • Previous autologous or allogenic stem cell transplant
  • Previous kidney transplant
  • History of seizure disorder
  • Patients who are on anti-epileptic therapy
  • Participation in a clinical trial in which the patient receives an investigational drug within a time period equal or less than 5.5 half-lives of the investigational agent prior to study enrollment.
  • Subjects who are unwilling or unable to discontinue immunosuppressive medications at the times of CART19 infusion will be excluded from the trial
  • Any comorbidity that in the opinion of the investigators would jeopardize the ability of the subject to tolerate therapy.
  • Pregnant patients. All participants of childbearing potential must have negative pregnancy test.
  • Lactating participants who want to continue breastfeeding.
  • Patients who are unwilling to consent to LTFU

Trial locations and contacts

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

Caitlin Elgarten, MD contact

267-425-7964

elgartenc@chop.edu

Melissa Varghese contact

845-553-5358

verghesem@chop.edu

United States1 site, 1 recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Caitlin Elgarten, MD, 267-425-7964, elgartenc@chop.edu

    Melissa Varghese, 845-553-5358, varghesem@chop.edu

    Recruiting

Other trials in United States

About this study

Official title: CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Adolescents and Young Adults With Systemic Lupus Erythematosus (SLE)

This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE).

Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.

Read the detailed description

Lupus disease activity is associated with increased numbers of activated naïve B cells and polyclonal expansion of antibody secreting cells, indicating a central role for B cells in the pathogenesis of SLE. While traditional anti-CD19 antibody therapies have been utilized with varying success in the treatment of Systemic lupus erythematosus (SLE), CD19 directed cellular therapies have emerged as an attractive therapeutic option that may lead to immunosuppression-free remission in this population given the ability of CD19 directed CAR T cells to more deeply deplete the B cell compartment. Previous clinical experience utilizing CD19 directed CAR T cells in patients diagnosed with Systemic lupus erythematosus (SLE) have exceeded any other Systemic lupus erythematosus (SLE) therapeutic available; although, those clinical trials have treated a limited number of subjects. During this trial the test article will be CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.

Being tested
CART19
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.

  • CART19Biological

    CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.

Study groups in NCT06839976
Study groupRoleWhat they receive
CART19ExperimentalParticipants will receive the study product. CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.
Receives: Biological: CART19

What is being measured

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

  1. Frequency of the dose limiting toxicities of CART19

    Frequency of the dose limiting toxicities of CART19

    Measured: up to 24 months post infusion

Secondary outcomes (9)

  1. Rate of childhood SLE Clinical Remission off steroids (cCR-0) within 12 months

    Measured: 12 months post treatment

  2. 2-year overall survival rate

    Measured: 24 months post infusion

  3. 2-year flare free survival rate

    Measured: up to 24 months post infusion

  4. Feasibility of manufacturing CART19 for participants with SLE

    Feasibility of manufacturing CART19 measured by the percentage of manufactured products that do not meet release criteria for vector transduction efficiency, T cell product purity, viability, or sterility

    Measured: up to 24 months post infusion

  5. Proportion of patients achieving a complete renal response

    renal response will be measured by urine protein/creatinine ratio of < 0.5, normal renal function (serum creatinine ≤ULN) without worsening of baseline serum creatinine by more than 15%, and inactive urinary sediment (<10 red blood cells (RBCs)/high-power field (HPF) without RBC casts)

    Measured: up to 24 months post infusion

  6. Proportion of patients achieving a partial renal response

    partial renal response will be measured by urine protein/creatinine ratio of < 0.5, normal renal function (serum creatinine ≤ULN) without worsening of baseline serum creatinine by more than 15%, and inactive urinary sediment (<10 red blood cells (RBCs)/high-power field (HPF) without RBC casts)

    Measured: up to 24 months post infusion

  7. Rate of CART19 expansion, persistence or B cell aplasia

    Rate of CART19 expansion, persistence and B cell aplasia will be measured by qPCR and flow cytometry

    Measured: up to 24 months post infusion

  8. Survival of CART19 cells

    CART19 cell survival will be measured by utilizing polymerase chain reaction analysis of whole blood to detect and quantify number of cells over time.

    Measured: up to 24 months post infusion

  9. Elevations in cytokines in serum

    to assess bioreactivity and biological response following CART cell infusion, systemic soluble immune and inflammatory factors will be measured by assessing any change in elevations in cytokines in serum prior to infusion and after.

    Measured: up to 24 months 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 posted21 Feb 2025
  2. Study start6 May 2025
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion28 Feb 2030 (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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06839976
Sponsor's protocol ID
24-022668
Status last verified
Sep 2026
First submitted
12 Feb 2025
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CART19 in people with SLE and Systemic Lupus Erythematosus (SLE), run by Children's Hospital of Philadelphia at 1 site in United States.

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 19 inclusion and 17 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 24 Sep 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 United States. 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 Caitlin Elgarten, MD (267-425-7964, elgartenc@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of the dose limiting toxicities of CART19 (time frame: up to 24 months post 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 NCT06839976.

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 24 Sep 2026.

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