BridgeMD
A clinical trial to learn about the effects of YTB in people with difficult to treat active systemic lupus erythematosus (SLE), or active kidney disease due to SLE
EU CTIS ID: 2023-510150-17-00
What this study is testing
To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to complete renal response (CRR) at Week 52 after rapcabtagene autoleucel infusion. To demonstrate the superiority of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion. To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to DORIS at Week 24 after rapcabtagene autoleucel infusion. To evaluate the efficacy of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion with respect to DORIS at Week 52 after rapcabtagene autoleucel infusion.
- Therapeutic exploratory (Phase II)
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 must be obtained prior to participation in the study.
- Men and women with SLE, aged ≥18 years and ≤75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE.
- Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory.
- Active lupus nephritis without signs of significant chronicity as defined by: retest during screening of any of the lab assessments for inclusion is permitted with an Investigator’s justification. Active SLE with non-renal significant organ involvement as defined by: BILAG-2004 disease activity level (Isenberg et al 2005, Yee et al 2006, Yee et al 2010, Isenberg et al 2011) in at least 1 of the following: • BILAG-2004 Level A disease in ≥ 1 organ system within the past 3 months with at least BILAG B in the same organ system at screening • BILAG-2004 Level B disease in ≥ 2 organ systems at screening
- points (Gladman et al 2002, Touma et al 2011), excluding points attributed to “fever”, “lupus headache”, "alopecia", and “organic brain syndrome.
You likely can't join if
- Any acute, severe lupus related-flare at and during screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy.
- Inadequate organ function during screening.
- History of, or current ECG or cardiac abnormalities indicating significant risk of safety for participants.
- Human immunodeficiency virus (HIV) positivity at screening.
- Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV).:
- Evidence of active or latent tuberculosis (TB) infection
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Korea, Republic of
- United States
- Israel
- United Kingdom
- Mexico
- Taiwan
- Singapore
- Argentina
- Brazil
- Canada
- Japan
- Australia
- Saudi Arabia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Korea, Republic of; United States; Israel; United Kingdom; Mexico and 8 more location(s). 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.