Phase
Condition
Scar Tissue
Treatment
rapcabtagene autoleucel
rituximab
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must fulfill the 2013 American College of Rheumatology/ European LeagueAgainst Rheumatism classification criteria for systemic sclerosis and meet thediffuse cutaneous SSc (dcSSc) subset classification according to LeRoy.
Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffyhands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to theScreening visit.
Severe, progressive systemic sclerosis disease defined by at least one of thefollowing:
Progressive systemic sclerosis-associated interstitial lung disease
Severe, progressive systemic sclerosis skin disease
Clinically significant systemic sclerosis-associated cardiac involvement atScreening
Exclusion
Exclusion Criteria:
Any condition during Screening that could prevent a complete washout of medicationsas required per protocol or could otherwise make the participant ineligible foranti-CD19 CAR-T therapy and further participation in the study, as judged by theInvestigator.
Participants with history of hypersensitivity to excipients in rapcabtageneautoleucel or to rituximab.
Any participant for whom treatment with rituximab is clinically inappropriate in theopinion of the investigator.
Any medical conditions that are not related to SSc that, in the opinion of theInvestigator, would jeopardize the ability of the participant to toleratelymphodepletion and anti-CD19 CAR-T cell therapy.
Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome orscleroderma myopathy), limited cutaneous systemic sclerosis (lcSSc) or sinescleroderma at Screening.
Participants with pre-existing pulmonary hypertension.
Significant renal pathology at Screening, including:
Active SSc renal crisis
Confirmed diagnosis of glomerulonephritis
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.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Novartis Investigative Site
Bordeaux Cedex, 33076
FranceActive - Recruiting
Novartis Investigative Site
Rennes, 35043
FranceActive - Recruiting
Novartis Investigative Site
Jena, 07740
GermanyActive - Recruiting
Novartis Investigative Site
Haifa, 3109601
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 52621
IsraelActive - Recruiting
Novartis Investigative Site
Ancona, AN 60126
ItalyActive - Recruiting
Novartis Investigative Site
Genova, GE 16132
ItalyActive - Recruiting
Novartis Investigative Site
Roma, RM 00168
ItalyActive - Recruiting
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanActive - Recruiting
Novartis Investigative Site
Kanazawa, Ishikawa 920 8641
JapanActive - Recruiting
Novartis Investigative Site
Singapore, 169608
SingaporeActive - Recruiting
Novartis Investigative Site
Barcelona, 08041
SpainActive - Recruiting
Novartis Investigative Site
Madrid, 28041
SpainActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
University Of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
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