RecruitingPhase 2NCT06655896

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

A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis

Sponsor

Novartis Pharmaceuticals

Enrollment

96 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Scleroderma, Diffuse

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing rapcabtagene autoleucel — a personalized CAR-T cell therapy made from the patient's own immune cells — in people with severe, progressive diffuse cutaneous systemic sclerosis (dcSSc), a serious form of scleroderma that causes the immune system to attack and scar the skin and internal organs. **You may be eligible if...** - You meet the recognized criteria for systemic sclerosis (scleroderma) - You have the diffuse cutaneous subtype with widespread skin thickening - Your disease started within the past 7 years and is progressing despite treatment - You have severe involvement of the lungs, skin, or heart due to scleroderma - You have received recommended vaccinations before enrollment **You may NOT be eligible if...** - You have the limited cutaneous form of scleroderma - Your disease is stable or improving on current treatment - You have serious infections, other autoimmune diseases, or major organ failure - Your disease onset was more than 7 years ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALrapcabtagene autoleucel

single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.

BIOLOGICALrituximab

rituximab intravenous infusion (i.v.) as per protocol

Locations(80)

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

Camperdown, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Graz, Austria

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Vienna, Austria

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São Paulo, São Paulo, Brazil

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Olomouc, Czechia

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Prague, Czechia

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Aarhus N, Denmark

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Bordeaux, France

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Dijon, France

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Lille, France

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Lyon, France

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Montpellier, France

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Paris, France

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Rennes, France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Göttingen, Lower Saxony, Germany

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Leipzig, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Jena, Thuringia, Germany

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Berlin, Germany

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Mainz, Germany

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Nuremberg, Germany

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Ulm, Germany

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Debrecen, Hajdu Bihar Megye, Hungary

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Budapest, Hungary

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Haifa, Israel

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Ramat Gan, Israel

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Tel Aviv, Israel

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Ancona, AN, Italy

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Bergamo, BG, Italy

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Brescia, BS, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Pescara, PE, Italy

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Perugia, PG, Italy

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Pisa, PI, Italy

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Pavia, PV, Italy

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Roma, RM, Italy

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Udine, UD, Italy

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Sapporo, Hokkaido, Japan

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Kanazawa, Ishikawa-ken, Japan

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Sendai, Miyagi, Japan

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Suita, Osaka, Japan

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Bunkyo-ku, Tokyo, Japan

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Fukuoka, Japan

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Kyoto, Japan

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Utrecht, Netherlands

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Singapore, Singapore

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Seoul, South Korea

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Santiago Compostela, A Coruna, Spain

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Santander, Cantabria, Spain

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Pamplona, Navarre, Spain

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Barcelona, Spain

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Barcelona, Spain

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Córdoba, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Salamanca, Spain

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Valencia, Spain

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Geneva, Switzerland

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Lausanne, Switzerland

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Zurich, Switzerland

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Taichung, Taiwan

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NCT06655896