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RecruitingPhase 1/Phase 2

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

Cabaletta Bio · NCT06121297

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
28
US sites recruiting
18
Study start
February 16, 2024
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: CABA-201; CABA-201

Conditions: Systemic Lupus Erythematosus; Lupus Nephritis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of California Irvine

    Orange, CA 92868

    Site contact: Anjali Symonette, MD · 714-456-8437 · asymonet@hs.uci.edu

  • UC Davis Health

    Sacramento, CA 95817

    Site contact: Avlyn Pooni · 916-734-0130 · alpooni@health.ucdavis.edu

  • Mayo Clinic

    Jacksonville, FL 32224

    Site contact: Wesley Dillinger · 904-953-3626 · Dillinger.wesley@mayo.edu

  • Emory University

    Atlanta, GA 30322

    Site contact: John Varghese · 404-727-2886 · john.varghese@emory.edu

  • Northwestern Memorial Hospital

    Chicago, IL 60611

    Site contact: Kaitlin King · 312-695-0990 · autoimmunesct@nm.org

  • The University of Chicago Medical Center - Accepting Adult and Adolescent Patients

    Chicago, IL 60637

    Site contact: Dr. Cuoghi Edens, MD, FAAP · 773-702-6119 · cedens@bsd.uchicago.edu

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Theresa Howard · 913-588-0653 · thoward2@kumc.edu

  • Tufts Medical Center

    Boston, MA 02111

    Site contact: Luis Tovar · 617-636-5558 · Luis.Tovar@tuftsmedicine.org

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Ben Bennett · 617-643-4395 · mgbennett@mgh.harvard.edu

  • Boston Children's Hospital - Accepting Young Adult and Adolescent Patients

    Boston, MA 02115

    Site contact: Bridget Kerwin · 617-632-5309 · BridgetO_Kerwin@DFCI.HARVARD.EDU

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Sydney Chase · 617-525-7638 · Schase9@bwh.harvard.edu

  • UMass Memorial Hospital

    Worcester, MA 01655

    Site contact: Cancer Research Office · 508-856-3216 · cancer.research@umassmed.edu

  • University of Minnesota

    Minneapolis, MN 55414

    Site contact: Patrick Nachman, MD · 612-624-9444 · pnachman@umn.edu

  • University of Rochester

    Rochester, NY 14642

    Site contact: Tyler Cavin · 585-273-2720 · Tyler_Cavin@URMC.Rochester.edu

  • UNC Chapel Hill

    Chapel Hill, NC 27599

    Site contact: Shruti Saxena Beem · 919-966-0545 · shruti_saxena@med.unc.edu

  • Children's Hospital of Philadelphia - Accepting Young Adult and Adolescent Patients

    Philadelphia, PA 19104

    Site contact: CARTintake@chop.edu · CARTintake@chop.edu

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Melissa Cunningham, MD, PhD · 866-859-6107 · lupusresearch@musc.edu

  • University of Texas MD Anderson Cancer Center

    Houston, TX 77030

    Site contact: Doris Soebbing, BS, RN, BSN · 832-247-8094 · DRSoebbing@mdanderson.org

Study contacts (from the official record)

  • Cabaletta Bio · 267 759 3100 · clinicaltrials@cabalettabio.com
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RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and… (NCT06121297) | Bored Studies