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An open-label study to assess safety, efficacy and cellular kinetics of YTB323 in severe, refractory systemic lupus erythematosus (srSLE).
EU CTIS ID: 2023-510081-27-00
What this study is testing
To assess safety of YTB323 in participants with srSLE.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 that can result in debilitating and permanent damage or may represent a life-threatening condition as judged by the investigator and defined by: - Renal - At least moderate or severe peri/myocarditis - At least moderate or severe pleuritis or other lung involvement - Vasculitis
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You likely can't join if
- 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.
- Sexually active males unwilling to use a condom during intercourse from the time enrollment for at least 12 months after YTB323 administration and until CAR-T cells are no longer present by qPCR on two consecutive tests.
- Any acute, severe lupus related 0000000 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,00000000000
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- 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 for at least 5 years by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
See the full eligibility criteria
Who can 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 that can result in debilitating and permanent damage or may represent a life-threatening condition as judged by the investigator and defined by: - Renal - At least moderate or severe peri/myocarditis - At least moderate or severe pleuritis or other lung involvement - Vasculitis
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What rules you out
- 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.
- Sexually active males unwilling to use a condom during intercourse from the time enrollment for at least 12 months after YTB323 administration and until CAR-T cells are no longer present by qPCR on two consecutive tests.
- Any acute, severe lupus related 0000000 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,00000000000
- 000000000000.
- 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 for at least 5 years 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 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).
- 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 (24 months in the US) after the YTB323 administration (unless local regulations mandate a longer duration) and until CAR-T cells are no longer present by qPCR on two consecutive tests.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.