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YTB323 for Lupus

Phase 1 & 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
B cell aplasia
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at how safe and effective YTB323 treatment is in patients with severe refractory systemic lupus erythematosus, and how the treatment affects the cells in their body.

Who is the study for?
This trial is for adults aged 18-65 with severe, treatment-resistant systemic lupus erythematosus (SLE). Participants must meet specific SLE criteria and have certain autoantibodies. They should have tried at least two immunosuppressive therapies without success and may also have kidney, heart, lung or blood vessel involvement. Major organ functions need to be adequate.
What is being tested?
The study tests YTB323's safety, effectiveness, and how it affects immune cells in patients with severe refractory SLE. It aims to see if this new treatment can help where others failed.
What are the potential side effects?
While the exact side effects of YTB323 are not listed here, similar treatments often cause immune system changes that might lead to infections or reactions at the infusion site; organ inflammation; fatigue; and possible impacts on blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney, liver, heart, blood, and lung functions are all within normal ranges.
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I am between 18 and 65 years old and have been diagnosed with SLE according to the 2019 EULAR/ACR criteria.
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My lupus is severe with significant organ involvement, excluding brain-related symptoms.
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I have not improved after trying two or more standard immune treatments and one biological agent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is B cell aplasia.
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I do not have any serious or recurring infections.
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I have had a bone marrow, stem cell, or organ transplant.
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I am not on any medications that the study does not allow.
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I have previously received treatments like CAR-T cell therapy.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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I do not have a severe lupus flare that needs immediate treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with AEs and SAEs
Secondary study objectives
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Area under plasma concentration -time AUC)
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Last measurable concentration Clast)
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in blood (Maximum observed blood concentration Cmax)
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: YTB323Experimental Treatment1 Intervention
Single infusion of YTB323

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,679 Total Patients Enrolled
8 Trials studying Lupus Nephritis
1,320 Patients Enrolled for Lupus Nephritis
~12 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
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