BridgeMD
A clinical trial to learn about the effects of YTB323 in people with difficult-to-treat severe inflammatory myopathies (IIM)
EU CTIS ID: 2024-514137-38-00
What this study is testing
To demonstrate the superiority of rapcabtagene autoleucel at a target dose of xx CAR-positive viable T cells, as a single infusion, over comparator (Investigator choice of treatment) with respect to achieving moderate to major improvement in the Total Improvement Score (TIS) at Week 52 for xx
- 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
- Male or female participants xx on the day of signing informed consent.
- A diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria.
- Participant must be xx based on an historical result xx
- Participants must have refractory xx:a. xx b. xx i. xx ii.xx iii. Xx iv. xx xx
- Diagnosed with active disease such as presence of at least 1 of the following criteria and confirmed by an adjudication committee for criteria b through e prior to randomization: xx
You likely can't join if
- Have severe muscle damage at Screening, as defined xx
- Participants treated with RTX xx prior to Screening or CYC xx prior to Baseline.
- Inadequate organ function (one retest during Screening of any of the below is permitted): Inadequate renal function (performed by central laboratory) defined as: • eGFR < 45 ml/min/1.73m2 using the 2021 CKD-EPI formula. Inadequate hepatic function defined as any of the following: • ALT and AST >1.5 × ULN (performed by central laboratory), except if clinically assessed as secondary to IIM • Total Bilirubin >1.5 × ULN (performed by central laboratory). Participants with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤1.5 × ULN. • International normalized ratio (INR) >1.5 (performed by central laboratory) Inadequate cardiac function defined as: • Left ventricular ejection fraction (LVEF) <50% as determined by echocardiogram (ECHO) Inadequate hematologic function (performed by central laboratory) defined as: • Absolute neutrophil count (ANC) <1500/mm3 • Platelets <100,000/μL • White blood cells count (WBC) <3,000 cells/μL • Absolute lymphocyte count <700/μL • Hemoglobin < 8.0 g/dL (< 4.9 mmol/L) Inadequate pulmonary function defined by ANY of the following: • Oxygen saturation measured by pulse xx • Hemoglobin corrected DLCO xx • FVC% xx
- Any participant who failed all available treatment options in the comparator arm or for whom these options are clinically inappropriate in the opinion of the Investigator.
- Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol (e.g., rapcabtagene autoleucel, comparator arm treatments, tocilizumab, xx, etc.), to the excipients of rapcabtagene autoleucel (e.g., xx), or to any other drug product as advised for administration in the study protocol (e.g., xx, G-CSF , tocilizumab).
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- Taiwan
- Saudi Arabia
- Australia
- Canada
- Brazil
- Israel
- Switzerland
- Singapore
- United Kingdom
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 Japan; United States; Taiwan; Saudi Arabia; Australia; Canada and 5 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.