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Systemic Lupus ErythematosusPhase 1/2NCT05798117

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus

A Phase 1/2 study testing YTB323 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Novartis Pharmaceuticals at 10 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus, Lupus Nephritis
What is being tested?
YTB323
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
10 sitesin 5 countries
Study dates
28 Feb 2023to 24 Sep 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Adequate renal, hepatic, cardiac, hematological and pulmonary function
  • Men and women with SLE, aged ≥18 years and ≤65 years at screening, fulfilling the 2019 European League Against Rheumatism EULAR/ACR classification criteria for SLE.
  • Patient must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer of ≥1:80, or anti dsDNA (above the ULN); or anti-Sm (above the ULN)
  • Active (severe) disease as defined by SLEDAI-2K ≥ 8 (not including the SLEDAI-2K domains of lupus headache, cerebrovascular accident, organic brain syndrome) and at least one of the following significant SLE related organ involvements:
  • Renal
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  • At least moderate or severe peri/myocarditis
  • At least moderate or severe pleuritis or other lung involvement
  • Vasculitis
  • Failure to respond to two or more standard immunosuppressive therapies (including one of mycophenolate or cyclophosphamide), unless contraindicated or having experienced documented adverse events or intolerance related to such immunosuppressive drugs not allowing their further use, in combination with glucocorticoids and failure to respond to at least one biological agent (unless contraindicated, the patient deemed ineligible by the Investigator or not available in a country).

Who cannot join

  • Clinically significant active, opportunistic, chronic or recurrent infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA, such as COVID-19 etc.) one month prior to or during screening. Patients who have had at least one severe infection that required prolonged hospitalization in the intensive care setting within 5 years prior to screening and/or at least one severe infection that required prolonged hospitalization within one year prior to screening.
  • Uncontrolled diabetes mellitus, lung diseases or any other illness that are not related to SLE that in the opinion of the Investigator would jeopardize the ability of the patient to tolerate lymphodepletion and CD19 CAR-T cell therapy
  • Prior history of malignancy except for localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis
  • Any patients requiring medications prohibited by the protocol
  • Any psychiatric condition or disability making compliance with treatment or informed consent impossible
  • Prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR-T cell therapy)
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  • History of bone marrow/hematopoietic stem cell or solid organ transplantation
  • Female participants who are pregnant or breastfeeding, or intending to conceive during the course of the study
  • Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a highly effective method of contraception starting from the time of enrollment to at least 12 months after the YTB323 infusion (or longer if required as per local regulations) and until CAR-T cells are no longer present by qPCR on two consecutive tests
  • Sexually active males unwilling to use a condom during intercourse from the time enrollment for at least 12 months after the YTB323 infusion and until CAR-T cells are no longer present by qPCR on two consecutive tests
  • Any acute, severe lupus related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible; thus, makes the patient ineligible for CD19 CAR-T therapy as judged by the Investigator, such as acute central nervous system (CNS) lupus (e.g. psychosis, epilepsy) or catastrophic antiphospholipid syndrome
  • Significant, likely irreversible organ damage related to SLE, e.g. end stage renal disease, that in the opinion of the Investigator renders CD19 CAR-T cell therapy would be unlikely to benefit the patient
  • B cell aplasia

Trial locations and contacts

10 sites in 5 countries.

10 sites in 5 countries

France3 sites

  • Novartis Investigative Site

    Paris, 75013

  • Novartis Investigative Site

    Pessac, 33604

  • Novartis Investigative Site

    Strasbourg, 67091

Other trials in France

Germany2 sites

  • Novartis Investigative Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Novartis Investigative Site

    Mainz, 55131

Other trials in Germany

Spain2 sites

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Madrid, 28009

Other trials in Spain

Switzerland2 sites

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Lausanne, 1011

Other trials in Switzerland

Australia1 site

  • Novartis Investigative Site

    Clayton, Victoria, 3168

Other trials in Australia

About this study

Official title: An Open-label, Multi-center, Phase 1/2 Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Participants With Severe, Refractory Systemic Lupus Erythematosus

The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.

Being tested
YTB323
Keywords
CAR-T, YTB323, Lupus, SLE, LN, severe refractory SLE
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.

  • YTB323Drug

    Single infusion of YTB323

Study groups in NCT05798117
Study groupRoleWhat they receive
YTB323ExperimentalSingle infusion of YTB323
Receives: Drug: YTB323

What is being measured

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

  1. Number of participants with AEs and SAEs

    Long term safety follow up

    Measured: Day 1 to 2 years

Secondary outcomes (15)

  1. CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Maximum observed blood concentration Cmax)

    Blood samples will be collected to assess cellular kinetics.

    Measured: Pre-dose, up to 2 years

  2. CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Area under plasma concentration -time AUC)

    Blood samples will be collected to assess cellular kinetics.

    Measured: Pre-dose, up to 2 years

  3. CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach maximum concentration Tmax)

    Blood samples will be collected to assess cellular kinetics.

    Measured: Pre-dose, up to 2 years

  4. CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Terminal elimination half-life T1/2)

    Blood samples will be collected to assess cellular kinetics.

    Measured: Pre-dose, up to 2 years

  5. CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Last measurable concentration Clast)

    Blood samples will be collected to assess cellular kinetics.

    Measured: Pre-dose, up to 2 years

  6. CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Time to reach last measurable concentration Tlast)

    Blood samples will be collected to assess cellular kinetics.

    Measured: Pre-dose, up to 2 years

  7. Number of patients with anti-drug antibodies

    Blood samples will be collected to measure anti-drug antibodies against YTB323.

    Measured: Pre-dose, up to 2 years

  8. Level of T cell activation by YTB323

    Blood samples will be collected to measure the level of T cell activation by YTB323.

    Measured: Pre-dose, up to 2 years

  9. Number of patients infused with planned target dose

    Feasibility of the manufacturing process in autoimmune disorders.

    Measured: Day 1

  10. Change from pre-dose up to 2 years in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score

    SLEDAI-2K scores are between 0 and 105, a higher score represents a higher disease activity.

    Measured: Pre-dose, up to 2 years

  11. Change from pre-dose up to 2 years in Physician's global assessment (PGA)

    The Physician's Global assessment is a visual analog scale from 0 to 3, 0 represents no activity and 3 represents severe disease activity.

    Measured: Pre-dose, up to 2 years

  12. Change from pre-dose up to 2 years in Lupus Low Disease Activity State (LLDAS)

    LLDAS is a composite measure based on: SLEDAI-2K ≤ 4, with no activity in major organ system (renal, central nervous system, cardiopulmonary, vasculitis, and fever) and no hemolytic anemia or gastrointestinal activity, current, no new lupus disease activity compared with the previous assessment, prednisone (or its equivalent) dose ≤ 7.5 mg/day, PGA (scale 0-3) ≤ 1, well tolerated standard maintenance doses of immunosuppressive lupus therapy.

    Measured: Pre-dose, up to 2 years

  13. Remission rate

    Remission as specified by Definitions Of Remission In Systemic Lupus Erythematosus (DORIS) criteria: Clinical SLEDAI=0, PGA<0.5 (0-3) irrespective of serology.

    The patient may be on antimalarials, low-dose glucocorticoids (prednisolone ≤5 mg/day), and/or stable immunosuppressive therapy including biologics.

    Measured: Up to 2 years

  14. Change from pre-dose up to 2 years in Urinary protein creatinine ratio (UPCR)

    Change in the value of UPCR.

    Measured: Pre-dose, up to 2 years

  15. Incidence of Complete renal response (CRR)

    Number of participants who achieved CRR.

    Measured: Up to 2 years

Timeline

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

  1. First posted4 Apr 2023
  2. Study start28 Feb 2023
  3. Primary completion24 Sep 2026
  4. Study completion24 Sep 2026

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798117
Sponsor's protocol ID
CYTB323G12101
Other IDs
2022-001796-14, 2023-510081-27-00, 2023
Status last verified
Oct 2026
First submitted
27 Feb 2023
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YTB323 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Novartis Pharmaceuticals at 10 sites in 5 countries.

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 10 inclusion and 13 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France, Germany, Spain, Switzerland, Australia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with AEs and SAEs (time frame: Day 1 to 2 years). 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 NCT05798117.

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 15 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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