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

April 7, 2026 updated by: Cabaletta Bio

A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Maisonneuve-Rosemont Hospital
        • Contact:
        • Principal Investigator:
          • Caroline Lamarche, MD
  • Spain
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Clinica Universitaria de Navarra
        • Contact:
  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine
        • Contact:
        • Principal Investigator:
          • Priyanka Iyer, MD
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health
        • Principal Investigator:
          • Gaurav Gulati, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Principal Investigator:
          • Fotios Koumpouras, M.D.
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Active, not recruiting
        • University of Florida Health
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Vikas Majithia, MBBS, MPH
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Principal Investigator:
          • Arezou Khosroshahi, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center
        • Principal Investigator:
          • Dr. Cuoghi Edens, MD, FAAP
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • Irene Blanco, MD
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Kimberly Liang, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Elena Massarotti, MD
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Meghan Sise, MD
        • Contact:
      • Boston, Massachusetts, United States, 02111
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Roberto Caricchio, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Patrick Nachman, MD, FASN
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia University Irving Medical Center
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
        • Principal Investigator:
          • Christopher Palma, MD, ScM
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Melissa Cunningham, MD, PhD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Biruh Workeneh, MD, FASN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Biological: CABA-201
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Biological: CABA-201
Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning
Experimental: CABA-201, No Preconditioning
Infusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE
Biological: CABA-201
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide
Biological: CABA-201
Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate incidence of adverse events
Time Frame: Up to 28 days after CABA-201 infusion
Up to 28 days after CABA-201 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate adverse events and laboratory abnormalities
Time Frame: 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)
Time Frame: Up to 156 weeks
Levels of B cells in the blood
Up to 156 weeks
To characterize the pharmacokinetics (PK)
Time Frame: Up to 156 weeks
Levels of CABA-201-positive T cells in the blood
Up to 156 weeks
To evaluate disease related biomarkers
Time Frame: Up to 156 weeks
Levels of C3, C4, and CH50 in serum
Up to 156 weeks
To evaluate disease related biomarkers
Time Frame: Up to 156 Weeks
Levels of anti-double stranded DNA (anti-dsDNA) in serum
Up to 156 Weeks
To evaluate efficacy
Time Frame: Up to 156 Weeks
Complete renal response rates (in subjects with LN)
Up to 156 Weeks
To evaluate efficacy
Time Frame: Up to 156 weeks
SRI-4, BICLA and DORIS remission and LLDAS response rates
Up to 156 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cabaletta Bio

Investigators

  • Study Chair: Medical Director, Cabaletta Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAB-201-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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