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Systemic Lupus ErythematosusPhase 1/2NCT06121297

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

A Phase 1/2 study testing CABA-201 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Cabaletta Bio at 23 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus, Lupus Nephritis
What is being tested?
CABA-201
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
23 sitesin 3 countries
Study dates
16 Feb 2024to Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

23 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Cabaletta Bio contact

267 759 3100 ext. 4444

clinicaltrials@cabalettabio.com

23 sites in 3 countries

United States21 sites, 18 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    John Varghese, 404-727-2886, john.varghese@emory.edu

    Arezou Khosroshahi, MD

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

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

    Andreas Klein, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Ben Bennett, 617-643-4395, mgbennett@mgh.harvard.edu

    Meghan Sise, MD

    Recruiting

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

    Boston, Massachusetts, 02115

    Bridget Kerwin, 617-632-5309, BridgetO_Kerwin@DFCI.HARVARD.EDU

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

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Sydney Chase, 617-525-7638, Schase9@bwh.harvard.edu

    Elena Massarotti, MD

    Recruiting

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

    Shruti Saxena Beem, 919-966-0545, shruti_saxena@med.unc.edu

    Roger Huamani, 919-966-5688, roger_huamani@med.unc.edu

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Melissa Cunningham, MD, PhD, 866-859-6107, lupusresearch@musc.edu

    Melissa Cunningham, MD, PhD

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Kaitlin King, 312-695-0990, autoimmunesct@nm.org

    Irene Blanco, MD

    Recruiting

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

    Chicago, Illinois, 60637

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

    Dr. Cuoghi Edens, MD, FAAP

    Recruiting

  • University of Florida Health

    Gainesville, Florida, 32610

    Active, not recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Doris Soebbing, BS, RN, BSN, 832-247-8094, DRSoebbing@mdanderson.org

    Biruh Workeneh, MD, FASN

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

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

    Vikas Majithia, MBBS, MPH

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Theresa Howard, 913-588-0653, thoward2@kumc.edu

    Kimberly Liang, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55414

    Patrick Nachman, MD, 612-624-9444, pnachman@umn.edu

    Patrick Nachman, MD, FASN

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Terminated

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Withdrawn

  • University of California Irvine

    Orange, California, 92868

    Anjali Symonette, MD, 714-456-8437, asymonet@hs.uci.edu

    Recruiting

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

    Philadelphia, Pennsylvania, 19104

    CARTintake@chop.edu, CARTintake@chop.edu

    CARTNurseNavigator@chop.edu, CARTNurseNavigator@chop.edu

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Tyler Cavin, 585-273-2720, Tyler_Cavin@URMC.Rochester.edu

    Christopher Palma, MD, ScM

    Recruiting

  • UC Davis Health

    Sacramento, California, 95817

    Avlyn Pooni, 916-734-0130, alpooni@health.ucdavis.edu

    Gaurav Gulati, MD

    Recruiting

  • UMass Memorial Hospital

    Worcester, Massachusetts, 01655

    Cancer Research Office, 508-856-3216, cancer.research@umassmed.edu

    Roberto Caricchio, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

    Karine Chaussé, 514-252-3400 ext. 3722, karine.chausse.cemtl@ssss.gouv.qc.ca

    Caroline Lamarche, MD

    Recruiting

Other trials in Canada

Spain1 site, 1 recruiting

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

    José Mora, +34948255400, jmora@unav.es

    Recruiting

Other trials in Spain

About this study

Official title: 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

Read the 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.

Being tested
CABA-201
Keywords
CABA-201, Autoimmune Disease, Anti-CD19 CAR-T therapy, Cellular Therapy, Systemic Lupus Erythematosus, Lupus Nephritis
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABA-201Biological

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

  • CABA-201Biological

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

Study groups in NCT06121297
Study groupRoleWhat they receive
CABA-201 with FLU/CY PreconditioningExperimentalLN 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
Receives: Biological: CABA-201
CABA-201, No PreconditioningExperimentalInfusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE
Receives: Biological: CABA-201

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate incidence of adverse events

    Measured: Up to 28 days after CABA-201 infusion

Secondary outcomes (7)

  1. To evaluate adverse events and laboratory abnormalities

    Incidence and severity of AEs, including changes in laboratory values and vital signs

    Measured: Up to 156 weeks

  2. To characterize the pharmacodynamics (PD)

    Levels of B cells in the blood

    Measured: Up to 156 weeks

  3. To characterize the pharmacokinetics (PK)

    Levels of CABA-201-positive T cells in the blood

    Measured: Up to 156 weeks

  4. To evaluate disease related biomarkers

    Levels of C3, C4, and CH50 in serum

    Measured: Up to 156 weeks

  5. To evaluate disease related biomarkers

    Levels of anti-double stranded DNA (anti-dsDNA) in serum

    Measured: Up to 156 Weeks

  6. To evaluate efficacy

    Complete renal response rates (in subjects with LN)

    Measured: Up to 156 Weeks

  7. To evaluate efficacy

    SRI-4, BICLA and DORIS remission and LLDAS response rates

    Measured: Up to 156 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start16 Feb 2024
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121297
Sponsor's protocol ID
CAB-201-001
Status last verified
Oct 2026
First submitted
23 Oct 2023
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CABA-201 in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Cabaletta Bio at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cabaletta Bio (267 759 3100 ext. 4444, clinicaltrials@cabalettabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate incidence of adverse events (time frame: Up to 28 days after CABA-201 infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06121297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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