Recruiting
Phase 1
Phase 2

CABA-201

Sponsor:

Cabaletta Bio

Code:

NCT06121297

Conditions

Systemic Lupus Erythematosus

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

CABA-201

CABA-201

Study Details

Brief summary:

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

Conditions

Systemic Lupus Erythematosus

Lupus Nephritis

Study ID

NCT06121297

Start date

Feb 16, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 and ≤65
  • A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult 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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: CABA-201, No Preconditioning

Infusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE

Interventions

CABA-201

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

CABA-201

Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning

Primary outcome measure

  • To evaluate incidence of adverse events [ Time Frame: Up to 28 days after CABA-201 infusion ]

Central Contacts and Locations

Central contacts

Cabaletta Bio

267 759 3100clinicaltrials@cabalettabio.com

Locations

University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Anjali Symonette, MD

714-456-8437asymonet@hs.uci.edu

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Avlyn Pooni

916-734-0130alpooni@health.ucdavis.edu

Principal Investigator:

Gaurav Gulati, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Wesley Dillinger

904-953-3626Dillinger.wesley@mayo.edu

Principal Investigator:

Vikas Majithia, MBBS, MPH

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

John Varghese

404-727-2886john.varghese@emory.edu

Principal Investigator:

Arezou Khosroshahi, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kaitlin King

312-695-0990autoimmunesct@nm.org

Principal Investigator:

Irene Blanco, MD

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Dr. Cuoghi Edens, MD, FAAP

773-702-6119cedens@bsd.uchicago.edu

Principal Investigator:

Dr. Cuoghi Edens, MD, FAAP

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Theresa Howard

913-588-0653thoward2@kumc.edu

Principal Investigator:

Kimberly Liang, MD

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Luis Tovar

617-636-5558Luis.Tovar@tuftsmedicine.org

Principal Investigator:

Andreas Klein, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ben Bennett

617-643-4395mgbennett@mgh.harvard.edu

Principal Investigator:

Meghan Sise, MD

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Bridget Kerwin

617-632-5309BridgetO_Kerwin@DFCI.HARVARD.EDU

Joyce Chang, MD

617-355-6117Joyce.Chang@childrens.harvard.edu

Principal Investigator:

Susan Prockop, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sydney Chase

617-525-7638Schase9@bwh.harvard.edu

Principal Investigator:

Elena Massarotti, MD

UMass Memorial Hospital

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Cancer Research Office

508-856-3216cancer.research@umassmed.edu

Principal Investigator:

Roberto Caricchio, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Patrick Nachman, MD

612-624-9444pnachman@umn.edu

Principal Investigator:

Patrick Nachman, MD, FASN

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Tyler Cavin

585-273-2720Tyler_Cavin@URMC.Rochester.edu

Principal Investigator:

Christopher Palma, MD, ScM

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Shruti Saxena Beem

919-966-0545shruti_saxena@med.unc.edu

Roger Huamani

919-966-5688roger_huamani@med.unc.edu

Principal Investigator:

Saira Sheikh, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

CARTintake@chop.edu

CARTintake@chop.edu

CARTNurseNavigator@chop.edu

CARTNurseNavigator@chop.edu

Principal Investigator:

Caitlin Elgarten

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Melissa Cunningham, MD, PhD

866-859-6107lupusresearch@musc.edu

Principal Investigator:

Melissa Cunningham, MD, PhD

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Doris Soebbing, BS, RN, BSN

832-247-8094DRSoebbing@mdanderson.org

Principal Investigator:

Biruh Workeneh, MD, FASN

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Karine Chaussé

514-252-3400karine.chausse.cemtl@ssss.gouv.qc.ca

Principal Investigator:

Caroline Lamarche, MD

More Information

Sponsor

Cabaletta Bio

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • CABA-201
  • Autoimmune Disease
  • Anti-CD19 CAR-T therapy
  • Cellular Therapy
  • Systemic Lupus Erythematosus
  • Lupus Nephritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cabaletta Bio on 2026-08-26.