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New treatment option for Scleroderma, Diffuse
Official title Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
ClinicalTrials.gov ID: NCT06655896
What this study is testing
What is rapcabtagene autoleucel?
rapcabtagene autoleucel is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for scleroderma, diffuse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
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...
- Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7...
- 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
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...
- 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...
- Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis...
- 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 and meet the diffuse cutaneous SSc (dcSSc) subset classification...
- 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
- All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients.
- 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...
- 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.
- Participants with uncontrolled stage II hypertension at Screening.
- Vaccination with live attenuated vaccines within 6 weeks prior to randomization. Other protocol-defined inclusion/exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- San Pablo, California, United States
- Zephyrhills, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Sioux Falls, South Dakota, United States
- Salt Lake City, Utah, United States
- CABA, Argentina
- Córdoba, Argentina
- Camperdown, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- Graz, Austria
- Vienna, Austria
- Ghent, Belgium
+ 65 more site(s).
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; San Pablo, California, United States; Zephyrhills, Florida, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States and 79 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 ClinicalTrials.gov; the study team decides eligibility.