Open-label undersøgelse til evaluering af sikkerheden og effektiviteten af CABA-201 hos forsøgspersoner med aktiv systemisk lupus erythematosus
5. oktober 2026 opdateret af: Cabaletta Bio
Et fase 1/2, åbent studie til evaluering af sikkerheden og effektiviteten af autologe CD19-specifikke kimære antigenreceptor-T-celler (CABA-201) hos forsøgspersoner med aktiv systemisk lupus erythematosus
RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by autoantibody production and abnormal B cell function. SLE presents with fluctuating severity and may cause tissue damage in a variety of organs over time. Lupus nephritis (LN) (renal involvement) is a common severe manifestation of SLE, which can lead to significant morbidity and mortality. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, also called resecabtagene autoleucel, or "rese-cel". Rese-cel can be given to patients with either LN or SLE without renal involvement, in two separate parallel cohorts, who have active disease. Initially a single dose of CABA-201 in patients pretreated with a standard regimen including cyclophosphamide (CY) and fludarabine (FLU), will be evaluated. In addition, escalating doses of CABA-201 will be evaluated in patients without CY and FLU pretreatment.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
28
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Cabaletta Bio
- Telefonnummer: 4444 267 759 3100
- E-mail: clinicaltrials@cabalettabio.com
Studiesteder
-
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Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Rekruttering
- Maisonneuve-Rosemont Hospital
-
Kontakt:
- Karine Chaussé
- Telefonnummer: 3722 514-252-3400
- E-mail: karine.chausse.cemtl@ssss.gouv.qc.ca
-
Ledende efterforsker:
- Caroline Lamarche, MD
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-
-
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California
-
Orange, California, Forenede Stater, 92868
- Rekruttering
- University of California Irvine
-
Kontakt:
- Anjali Symonette, MD
- Telefonnummer: 714-456-8437
- E-mail: asymonet@hs.uci.edu
-
Sacramento, California, Forenede Stater, 95817
- Rekruttering
- UC Davis Health
-
Ledende efterforsker:
- Gaurav Gulati, MD
-
Kontakt:
- Avlyn Pooni
- Telefonnummer: 916-734-0130
- E-mail: alpooni@health.ucdavis.edu
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Afsluttet
- Yale University
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Florida
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Gainesville, Florida, Forenede Stater, 32610
- Aktiv, ikke rekrutterende
- University of Florida Health
-
Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic
-
Kontakt:
- Wesley Dillinger
- Telefonnummer: 904-953-3626
- E-mail: Dillinger.wesley@mayo.edu
-
Ledende efterforsker:
- Vikas Majithia, MBBS, MPH
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University
-
Kontakt:
- John Varghese
- Telefonnummer: 404-727-2886
- E-mail: john.varghese@emory.edu
-
Ledende efterforsker:
- Arezou Khosroshahi, MD
-
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Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern Memorial Hospital
-
Ledende efterforsker:
- Irene Blanco, MD
-
Kontakt:
- Kaitlin King
- Telefonnummer: 312-695-0990
- E-mail: autoimmunesct@nm.org
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- The University of Chicago Medical Center - Accepting Adult and Adolescent Patients
-
Ledende efterforsker:
- Dr. Cuoghi Edens, MD, FAAP
-
Kontakt:
- Dr. Cuoghi Edens, MD, FAAP
- Telefonnummer: 773-702-6119
- E-mail: cedens@bsd.uchicago.edu
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- Rekruttering
- University of Kansas Medical Center
-
Kontakt:
- Theresa Howard
- Telefonnummer: 913-588-0653
- E-mail: thoward2@kumc.edu
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Ledende efterforsker:
- Kimberly Liang, MD
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Rekruttering
- Brigham and Women's Hospital
-
Ledende efterforsker:
- Elena Massarotti, MD
-
Kontakt:
- Sydney Chase
- Telefonnummer: 617-525-7638
- E-mail: Schase9@bwh.harvard.edu
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
-
Ledende efterforsker:
- Meghan Sise, MD
-
Kontakt:
- Ben Bennett
- Telefonnummer: 617-643-4395
- E-mail: mgbennett@mgh.harvard.edu
-
Boston, Massachusetts, Forenede Stater, 02111
- Rekruttering
- Tufts Medical Center
-
Ledende efterforsker:
- Andreas Klein, MD
-
Kontakt:
- Luis Tovar
- Telefonnummer: 617-636-5558
- E-mail: Luis.Tovar@tuftsmedicine.org
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Boston, Massachusetts, Forenede Stater, 02115
- Rekruttering
- Boston Children's Hospital - Accepting Young Adult and Adolescent Patients
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Ledende efterforsker:
- Susan Prockop, MD
-
Kontakt:
- Bridget Kerwin
- Telefonnummer: 617-632-5309
- E-mail: BridgetO_Kerwin@DFCI.HARVARD.EDU
-
Kontakt:
- Joyce Chang, MD
- Telefonnummer: 617-355-6117
- E-mail: Joyce.Chang@childrens.harvard.edu
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Worcester, Massachusetts, Forenede Stater, 01655
- Rekruttering
- UMass Memorial Hospital
-
Kontakt:
- Cancer Research Office
- Telefonnummer: 508-856-3216
- E-mail: cancer.research@umassmed.edu
-
Ledende efterforsker:
- Roberto Caricchio, MD
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55414
- Rekruttering
- University of Minnesota
-
Ledende efterforsker:
- Patrick Nachman, MD, FASN
-
Kontakt:
- Patrick Nachman, MD
- Telefonnummer: 612-624-9444
- E-mail: pnachman@umn.edu
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New York
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New York, New York, Forenede Stater, 10032
- Trukket tilbage
- Columbia University Irving Medical Center
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Rochester, New York, Forenede Stater, 14642
- Rekruttering
- University of Rochester
-
Kontakt:
- Tyler Cavin
- Telefonnummer: 585-273-2720
- E-mail: Tyler_Cavin@URMC.Rochester.edu
-
Ledende efterforsker:
- Christopher Palma, MD, ScM
-
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Rekruttering
- UNC Chapel Hill
-
Kontakt:
- Shruti Saxena Beem
- Telefonnummer: 919-966-0545
- E-mail: shruti_saxena@med.unc.edu
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Kontakt:
- Roger Huamani
- Telefonnummer: 919-966-5688
- E-mail: roger_huamani@med.unc.edu
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Ledende efterforsker:
- Saira Sheikh, MD
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- Children's Hospital of Philadelphia - Accepting Young Adult and Adolescent Patients
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Ledende efterforsker:
- Caitlin Elgarten
-
Kontakt:
- CARTintake@chop.edu
- E-mail: CARTintake@chop.edu
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Kontakt:
- CARTNurseNavigator@chop.edu
- E-mail: CARTNurseNavigator@chop.edu
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Rekruttering
- Medical University of South Carolina
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Kontakt:
- Melissa Cunningham, MD, PhD
- Telefonnummer: 866-859-6107
- E-mail: lupusresearch@musc.edu
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Ledende efterforsker:
- Melissa Cunningham, MD, PhD
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Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center
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Ledende efterforsker:
- Biruh Workeneh, MD, FASN
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Kontakt:
- Doris Soebbing, BS, RN, BSN
- Telefonnummer: 832-247-8094
- E-mail: DRSoebbing@mdanderson.org
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Rekruttering
- Clinica Universitaria de Navarra
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Kontakt:
- José Mora
- Telefonnummer: +34948255400
- E-mail: jmora@unav.es
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
12 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age ≥18 and ≤65 (Adults) or Age ≥12 to <18 years (Adolescents)
- A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE.
- Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening.
- For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
- For non-renal SLE subjects only: Active, moderate to severe SLE
Exclusion Criteria:
- Contraindication to leukapheresis
- History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
- Active infection requiring medical intervention at screening
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
- Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
- For LN subjects only: The presence of kidney disease other than active lupus nephritis
- Previous CAR T cell therapy
- Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: CABA-201 with FLU/CY Preconditioning
LN Cohort: Infusion of CABA-201 with preconditioning in subjects with LN Non-renal SLE Cohort: Infusion of CABA-201 with preconditioning in subjects with non-renal SLE who do not meet criteria for inclusion in the LN cohort Expansion Cohort: Infusion of CABA-201 with preconditioning in subjects with LN and SLE |
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning |
|
Eksperimentel: CABA-201, No Preconditioning
Infusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE |
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
For at evaluere forekomsten af uønskede hændelser
Tidsramme: Op til 28 dage efter CABA-201 infusion
|
Op til 28 dage efter CABA-201 infusion
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate adverse events and laboratory abnormalities
Tidsramme: Up to 156 weeks
|
Incidence and severity of AEs, including changes in laboratory values and vital signs |
Up to 156 weeks
|
|
To characterize the pharmacodynamics (PD)
Tidsramme: Up to 156 weeks
|
Levels of B cells in the blood |
Up to 156 weeks
|
|
To characterize the pharmacokinetics (PK)
Tidsramme: Up to 156 weeks
|
Levels of CABA-201-positive T cells in the blood |
Up to 156 weeks
|
|
To evaluate disease related biomarkers
Tidsramme: Up to 156 weeks
|
Levels of C3, C4, and CH50 in serum |
Up to 156 weeks
|
|
To evaluate disease related biomarkers
Tidsramme: Up to 156 Weeks
|
Levels of anti-double stranded DNA (anti-dsDNA) in serum |
Up to 156 Weeks
|
|
To evaluate efficacy
Tidsramme: Up to 156 Weeks
|
Complete renal response rates (in subjects with LN) |
Up to 156 Weeks
|
|
To evaluate efficacy
Tidsramme: Up to 156 weeks
|
SRI-4, BICLA and DORIS remission and LLDAS response rates |
Up to 156 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Medical Director, Cabaletta Bio
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. februar 2024
Primær færdiggørelse (Anslået)
1. december 2029
Studieafslutning (Anslået)
1. december 2029
Datoer for studieregistrering
Først indsendt
23. oktober 2023
Først indsendt, der opfyldte QC-kriterier
1. november 2023
Først opslået (Faktiske)
7. november 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Bindevævssygdomme
- Sygdomme i immunsystemet
- Glomerulonefritis
- Nefritis
- Hud- og bindevævssygdomme
- Lupus erythematosus, systemisk
- Lupus nefritis
- Autoimmune sygdomme
Andre undersøgelses-id-numre
- CAB-201-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .