BridgeMD
A clinical trial to learn about the effects of YTB323 in people with difficult to treat severe diffuse cutaneous systemic sclerosis (dcSSc)
EU CTIS ID: 2023-510380-34-00
What this study is testing
To demonstrate the superiority of rapcabtagene autoleucel at a target dose of CAR-positive viable T cells as a single infusion compared to rituximab, with respect to the proportion of participants achieving a Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) response at Week 52
- 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
- Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis (van den Hoogen et al 2013) and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy (LeRoy et al 1988)
- Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit
- Severe, progressive systemic sclerosis disease defined by at least one of the following: • Progressive systemic sclerosis-associated interstitial lung disease • Severe, progressive systemic sclerosis skin disease • Clinically significant systemic sclerosis-associated cardiac involvement at Screening
You likely can't join if
- Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator
- Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab
- Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator
- Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy
- Rheumatic disease other than dcSSc, (except secondary Sjogren’s syndrome or scleroderma myopathy), including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening
- Participants with pre-existing pulmonary hypertension.
See the full eligibility criteria
- Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis (van den Hoogen et al 2013) and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy (LeRoy et al 1988)
- Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit
- Severe, progressive systemic sclerosis disease defined by at least one of the following: • Progressive systemic sclerosis-associated interstitial lung disease • Severe, progressive systemic sclerosis skin disease • Clinically significant systemic sclerosis-associated cardiac involvement at Screening
- Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator
- Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab
- Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator
- Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy
- Rheumatic disease other than dcSSc, (except secondary Sjogren’s syndrome or scleroderma myopathy), including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening
- Participants with pre-existing pulmonary hypertension.
- Significant renal pathology at Screening, including: • Scleroderma renal crisis • Confirmed diagnosis of glomerulonephritis
- Participants with uncontrolled stage II hypertension at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
- Korea, Republic of
- Singapore
- Japan
- Canada
- Brazil
- Argentina
- Australia
- United Kingdom
- Taiwan
- Mexico
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States; Korea, Republic of; Singapore; Japan; Canada and 7 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.