One-Time cell therapy aims to tame tough scleroderma

NCT ID NCT06655896

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study tests a new treatment called rapcabtagene autoleucel, made from a patient's own immune cells, for people with severe scleroderma that hasn't improved with standard care. About 96 participants will receive either this one-time cell therapy or the current drug rituximab. The goal is to see if the cell therapy can better improve skin hardening and lung function after one year.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: rapcabtagene autoleucel (a cell therapy made from the patient's own immune cells)
What this could lead to: If it works, this could offer a more effective, one-time treatment option for people with severe scleroderma that hasn't responded to other therapies.
What could go wrong: This is a phase 2 trial with only 96 participants, so results are preliminary. The cell therapy requires strong chemotherapy beforehand, which carries serious risks like infection and organ damage.

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCLERODERMA, DIFFUSE

Contacts and locations

Locations

Avera Cancer
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Sioux Falls, South Dakota, 57105, United States
Boston Medical Center
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Boston, Massachusetts, 02118, United States
FL Medical Clinic Orlando Health
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Zephyrhills, Florida, 33542, United States
James Cancer Hospital
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Columbus, Ohio, 43210, United States
LDS Hospital
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Salt Lake City, Utah, 84143, United States
Michigan Med University of Michigan
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Ann Arbor, Michigan, 48109 5271, United States
Northwestern University
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Chicago, Illinois, 60611, United States
Novartis Investigative Site
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CABA, C1181ACH, Argentina
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Córdoba, X5016KEH, Argentina
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Camperdown, New South Wales, 2050, Australia
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Darlinghurst, New South Wales, 2010, Australia
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Graz, 8036, Austria
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Vienna, 1090, Austria
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Ghent, 9000, Belgium
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Salvador, Estado de Bahia, 41253-190, Brazil
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Curitiba, Paraná, 80030-110, Brazil
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Barretos, São Paulo, 14784 400, Brazil
Novartis Investigative Site
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São Paulo, São Paulo, 01232-010, Brazil
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São Paulo, São Paulo, 01308-050, Brazil
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Olomouc, 779 00, Czechia
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Prague, 128 00, Czechia
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Aarhus N, 8200, Denmark
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Bordeaux, 33076, France
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Dijon, 21000, France
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Lille, 59037, France
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Lyon, 69003, France
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Montpellier, 34295, France
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Paris, 75014, France
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Rennes, 35033, France
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Strasbourg, 67091, France
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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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Göttingen, Lower Saxony, 37075, Germany
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Leipzig, Saxony, 04103, Germany
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Halle, Saxony-Anhalt, 06120, Germany
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Jena, Thuringia, 07740, Germany
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Berlin, 13353, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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Nuremberg, 90419, Germany
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Ulm, 89081, Germany
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Debrecen, Hajdu Bihar Megye, 4032, Hungary
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Budapest, H-1083, Hungary
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Haifa, 3109601, Israel
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Ramat Gan, 5265601, Israel
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Tel Aviv, 6423906, Israel
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Ancona, AN, 60020, Italy
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Bergamo, BG, 24127, Italy
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Brescia, BS, 25123, Italy
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Genova, GE, 16132, Italy
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Milan, MI, 20122, Italy
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Milan, MI, 20132, Italy
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Pescara, PE, 65124, Italy
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Perugia, PG, 06129, Italy
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Pisa, PI, 56126, Italy
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Pavia, PV, 27100, Italy
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Roma, RM, 00168, Italy
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Udine, UD, 33100, Italy
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Sapporo, Hokkaido, 060-8648, Japan
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Sendai, Miyagi, 9808574, Japan
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Suita, Osaka, 565-0871, Japan
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Bunkyo-ku, Tokyo, 113-8603, Japan
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Fukuoka, 8128582, Japan
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Ishikawa, 9208641, Japan
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Kyoto, 6068507, Japan
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Utrecht, 3584 CX, Netherlands
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Singapore, 169608, Singapore
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Seoul, 04763, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Santiago Compostela, A Coruna, 15706, Spain
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Santander, Cantabria, 39008, Spain
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Pamplona, Navarre, 31008, Spain
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Barcelona, 08035, Spain
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Barcelona, 08041, Spain
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Córdoba, 14004, Spain
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Madrid, 28009, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Salamanca, 37007, Spain
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Valencia, 46026, Spain
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Geneva, 1211, Switzerland
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Lausanne, 1011, Switzerland
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Zurich, 8091, Switzerland
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Taichung, 407219, Taiwan
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Sheffield, South Yorkshire, S10 2JF, United Kingdom
Oregon Health Sciences University
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Portland, Oregon, 97239, United States
Sutter Health Network
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San Pablo, California, 94806, United States
UCLA
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Los Angeles, California, 90095, United States
UCSF
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San Francisco, California, 94115, United States
UCSF
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San Francisco, California, 94115, United States
University Of Iowa
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Iowa City, Iowa, 52242, United States
University of Minnesota
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Minneapolis, Minnesota, 55455, United States

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