Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

Recruiting · NCT06655896 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals

View the official record on ClinicalTrials.gov →

Multiple sclerosis

Interventions studied

rapcabtagene autoleucel rituximab

What this trial is about

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.

Who can take part

Age range

18 Years to 70 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

Inclusion 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 according to LeRoy.
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.

Exclusion criteria

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.
Participants with uncontrolled stage II hypertension at Screening.
Vaccination with live attenuated vaccines within 6 weeks prior to randomization.
ther protocol-defined inclusion/exclusion criteria may apply.

Where it is running

60 locations listed across 11 US states.

UCLA - Los Angeles, California, United States
UCSF - San Francisco, California, United States
UCSF - San Francisco, California, United States
Sutter Health Network - San Pablo, California, United States
FL Medical Clinic Orlando Health - Zephyrhills, Florida, United States
Northwestern University - Chicago, Illinois, United States
University Of Iowa - Iowa City, Iowa, United States
Boston Medical Center - Boston, Massachusetts, United States
Michigan Med University of Michigan - Ann Arbor, Michigan, United States
University of Minnesota - Minneapolis, Minnesota, United States
James Cancer Hospital - Columbus, Ohio, United States
Oregon Health Sciences University - Portland, Oregon, United States
Avera Cancer - Sioux Falls, South Dakota, United States
LDS Hospital - Salt Lake City, Utah, United States
Novartis Investigative Site - Aarhus N, Denmark
Novartis Investigative Site - Barcelona, Spain
Novartis Investigative Site - Barcelona, Spain
Novartis Investigative Site - Berlin, Germany
Novartis Investigative Site - Bordeaux, France
Novartis Investigative Site - Budapest, Hungary
Novartis Investigative Site - CABA, Argentina
Novartis Investigative Site - Córdoba, Spain
Novartis Investigative Site - Dijon, France
Novartis Investigative Site - Fukuoka, Japan
Novartis Investigative Site - Geneva, Switzerland
Novartis Investigative Site - Ghent, Belgium
Novartis Investigative Site - Graz, Austria
Novartis Investigative Site - Haifa, Israel
Novartis Investigative Site - Ishikawa, Japan
Novartis Investigative Site - Kyoto, Japan
Novartis Investigative Site - Lausanne, Switzerland
Novartis Investigative Site - Lille, France
Novartis Investigative Site - Lyon, France
Novartis Investigative Site - Lübeck, Germany
Novartis Investigative Site - Madrid, Spain
Novartis Investigative Site - Madrid, Spain
Novartis Investigative Site - Mainz, Germany
Novartis Investigative Site - Montpellier, France
Novartis Investigative Site - Málaga, Spain
Novartis Investigative Site - Nuremberg, Germany
Novartis Investigative Site - Olomouc, Czechia
Novartis Investigative Site - Paris, France
Novartis Investigative Site - Prague, Czechia
Novartis Investigative Site - Ramat Gan, Israel
Novartis Investigative Site - Rennes, France
Novartis Investigative Site - Salamanca, Spain
Novartis Investigative Site - Seoul, South Korea
Novartis Investigative Site - Seoul, South Korea
Novartis Investigative Site - Singapore, Singapore
Novartis Investigative Site - Strasbourg, France
Novartis Investigative Site - Taichung, Taiwan
Novartis Investigative Site - Tel Aviv, Israel
Novartis Investigative Site - Ulm, Germany
Novartis Investigative Site - Utrecht, Netherlands
Novartis Investigative Site - Valencia, Spain
Novartis Investigative Site - Vienna, Austria
Novartis Investigative Site - Vienna, Austria
Novartis Investigative Site - Zurich, Switzerland
Novartis Investigative Site - Santiago Compostela, A Coruna, Spain
Novartis Investigative Site - Ancona, AN, Italy

Showing 60 of 94 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →