Engineered immune cells aim to tame lupus without daily pills
NCT ID NCT07015983
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This phase 2 trial tests a one-time treatment called CC-97540, made from a patient's own immune cells engineered to target and calm the overactive immune system in lupus. The study enrolls 89 adults with active lupus (including kidney inflammation) who have not responded well to steroids and at least two other immunosuppressants. The main goal is to see if participants can achieve drug-free remission, meaning no lupus symptoms and no need for lupus medications.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- CC-97540 (a type of CAR T-cell therapy that targets CD19 on immune cells)
- What this could lead to
- If successful, this could offer a new treatment option that allows people with lupus to stop taking daily medications and achieve long-term remission.
- What could go wrong
- This is an early phase 2 trial with only 89 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162, Italy
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Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901, United States
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Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
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Baylor Scott and White Research Institute
Dallas, Texas, 75246, United States
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CHU Montpellier Lapeyronie Hospital
Montpellier, Hérault, 34295, France
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Carolinas HealthCare System SouthPark
Charlotte, North Carolina, 28211, United States
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Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
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Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, Lisbon District, 1649-035, Portugal
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Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117, Germany
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Chiba University Hospital
Chiba, 260-8677, Japan
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Columbia University Pediatrics
New York, New York, 10032, United States
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Derriford Hospital, University Hospitals Plymouth NHS Trust
Crownhill, Plymouth, PL6 8DH, United Kingdom
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Emory University School of Medicine
Atlanta, Georgia, 30322, United States
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Florida Medical Clinic Orlando Health
Zephyrhills, Florida, 33542, United States
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
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H.R.U Málaga - Hospital General
Málaga, 29011, Spain
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Hadassah Medical Center
Jerusalem, 9112001, Israel
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Hokkaido University Hospital
Sapporo, Hokkaido, 0608648, Japan
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Hospital Aleman
Buenos Aires, Buenos Aires F.D., C1118AAT, Argentina
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Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120, Spain
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Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB, Argentina
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Hospital La Princesa
Madrid, 28006, Spain
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Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
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Hospital for Special Surgery
New York, New York, 10021, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
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Keio university hospital
Shinjuku-ku, Tokyo, 1608582, Japan
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King's College Hospital
London, London, City of, SE5 9RL, United Kingdom
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Kyushu University Hospital
Fukuoka, 812-8582, Japan
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Local Institution - 0011
Rochester, Minnesota, 55905, United States
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Local Institution - 0021
São Paulo, São Paulo, 01409-001, Brazil
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Local Institution - 0022
São Paulo, 05652-900, Brazil
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Local Institution - 0038
Los Angeles, California, 90027, United States
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Local Institution - 0047
Copenhagen, Capital Region, 2100, Denmark
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Local Institution - 0051
Los Angeles, California, 90095, United States
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Local Institution - 0058
São Paulo, São Paulo, 01509-010, Brazil
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Local Institution - 0070
Pisa, Tuscany, 56126, Italy
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Local Institution - 0073
Orlando, Florida, 32803, United States
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Local Institution - 0077
Córdoba, X5016, Argentina
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Local Institution - 0079
Atlanta, Georgia, 30322, United States
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Local Institution - 0081
Toulouse, Haute-Garonne, 31059, France
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Local Institution - 0082
New York, New York, 10016, United States
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Local Institution - 0083
Philadelphia, Pennsylvania, 19104, United States
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Local Institution - 0086
Baton Rouge, Louisiana, 70836, United States
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Local Institution - 0088
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
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Local Institution - 0090
Metropolitan Borough of Wirral, Merseyside, L63 4JY, United Kingdom
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Local Institution - 0091
Liverpool, L9 7AL, United Kingdom
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Local Institution - 0093
Newport Beach, California, 92663, United States
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Local Institution - 0094
Boston, Massachusetts, 02114, United States
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Local Institution - 0096
Ann Arbor, Michigan, 48109, United States
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Local Institution - 0098
Dallas, Texas, 75390-9068, United States
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Local Institution - 0099
Toronto, Ontario, M5T 2S8, Canada
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Local Institution - 0101
Manhasset, New York, 11030, United States
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Local Institution - 0104
San Antonio, Texas, 78229, United States
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Local Institution - 0106
Phoenix, Arizona, 85054, United States
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Local Institution - 0107
Buenos Aires, B1629ODT, Argentina
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Local Institution - 0108
Indianapolis, Indiana, 46250, United States
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Local Institution - 0109
Strasbourg, 67098, France
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Local Institution - 0110
Shreveport, Louisiana, 71101, United States
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Local Institution - 0111
Stony Brook, New York, 11794, United States
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Local Institution - 0132
Odense, Region Syddanmark, 5000, Denmark
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Local Institution - 0134
Paris, Île-de-France Region, 75015, France
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Local Institution - 0135
Winston-Salem, North Carolina, 27106, United States
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Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
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Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
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Medizinische Universität Wien
Vienna, State of Vienna, 1090, Austria
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Narodowy Instytut Onkologii - Oddzial w Gliwicach
Gliwice, Silesian Voivodeship, 44-101, Poland
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Northside Hospital
Atlanta, Georgia, 30342, United States
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Odense Universitetshospital
Odense, Region Syddanmark, 5000, Denmark
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Okayama University Hospital
Okayama, 700-8558, Japan
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Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
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Ospedale Pediatrico Bambino Gesù IRCCS
Rome, Roma, 00165, Italy
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Pitie Salpetriere University Hospital
Paris, Île-de-France Region, 75013, France
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Rheumazentrum Ruhrgebiet
Herne, 44649, Germany
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Sheba Medical Center
Ramat Gan, Central District, 5262100, Israel
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Swedish Medical Center
Seattle, Washington, 98122, United States
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Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, 41-902, Poland
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The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
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USF Health
Tampa, Florida, 33612, United States
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UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
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Uniklinikum Salzburg
Salzburg, 5020, Austria
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Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
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Universitaetsklinikum Koeln
Cologne, 50937, Germany
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Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
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University College London Hospital
London, London, City of, NW1 2PG, United Kingdom
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136, United States
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Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
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Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
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Weill Cornell Medical College
New York, New York, 10065, United States
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Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A simple blood test may reveal kidney damage in lupus — no biopsy needed?
- Can a Three-Drug combo quiet lupus kidney flares?
- Can a new antibody help lupus patients ditch steroids?
- Can a single infusion tame tough lupus?
- Can a smartphone app bridge the lupus care gap for women of color?
- Can a single drug calm lupus kidney disease without a cocktail of meds?